FDA FOIA Log - May 2023

Control # Recd Date From
2023-3468 05/01/2023 FDAZILLA
2023-3469 05/01/2023 Harrington Films

2023-3470 05/01/2023 Melton, Donavan
Advocate Lutheran General
2023-3472 05/01/2023 Hospital
SINTETICA SA
2023-3473 05/01/2023 PHARMACEUTICALS
2023-3474 05/01/2023 FOI Services, Inc.
2023-3475 05/01/2023 ON POINT INVESTIGATIONS
2023-3476 05/01/2023 Merck&Co., Inc
BALYASNY ASSET
2023-3477 05/01/2023 MANAGEMENT
2023-3478 05/01/2023 Styrax Cap
2023-3479 05/01/2023 Kulkarni, Nivedita T
2023-3480 05/01/2023 Sung Chun Kim, Esq.

2023-3481 05/01/2023 Acuta Capital Partners
2023-3484 05/01/2023 POINT72
2023-3485 05/01/2023 POINT72

2023-3486 05/01/2023 PAREXEL
2023-3487 05/01/2023 ZH
2023-3488 05/01/2023 FOI Services, Inc.
2023-3489 05/01/2023 MPG Operations LLC

THOMSON REUTERS COURT
2023-3490 05/01/2023 EXPRESS
2023-3491 05/01/2023 IVERIC bio
2023-3492 05/01/2023 Athenex, Inc.
2023-3493 05/01/2023 Athenex, Inc.
2023-3494 05/01/2023 BLOOMBERG NEWS

Motilal oswal financial
2023-3495 05/01/2023 services
2023-3496 05/01/2023 BN
FAVUS INSTITUTIONAL
2023-3497 05/01/2023 RESEARCH LLC
FAVUS INSTITUTIONAL
2023-3498 05/01/2023 RESEARCH LLC
2023-3499 05/01/2023 BQ Prime
2023-3500 05/01/2023 Dolat Capital Market Limited
2023-3501 05/01/2023 SIRI & GLIMSTAD LLP

2023-3502 05/01/2023 FDA NEWS
2023-3503 05/01/2023 FDA NEWS
2023-3504 05/01/2023 FDA NEWS
2023-3505 05/01/2023 FDA NEWS
2023-3508 05/01/2023 FOIA Professional Services
2023-3510 05/01/2023 Revance Therapeutics, Inc.

Powers Regulatory
2023-3511 05/01/2023 Consulting
2023-3512 05/01/2023 FOI Services, Inc.
2023-3513 05/01/2023 THE WASHINGTON POST
2023-3515 05/01/2023 FOI Services, Inc.
2023-3517 05/01/2023 Redica Systems
2023-3518 05/01/2023 Redica Systems
2023-3519 05/01/2023 Redica Systems
2023-3520 05/01/2023 Redica Systems
2023-3521 05/01/2023 Redica Systems
2023-3522 05/01/2023 Redica Systems
2023-3523 05/01/2023 Redica Systems
2023-3524 05/01/2023 Redica Systems
2023-3525 05/01/2023 Redica Systems
2023-3526 05/01/2023 Redica Systems

AMERICAN HERBAL
2023-3527 05/01/2023 PRODUCTS ASSOCIATION
2023-3528 05/01/2023 Boston Foundation for Sight
2023-3529 05/01/2023 CNBC
2023-3530 05/01/2023 FDAZILLA

2023-3531 05/01/2023 Knoepfler, Jackson W
2023-3532 05/01/2023 Brown & Crouppen, P.C.
2023-3533 05/01/2023 FOI Services, Inc.

2023-3534 05/01/2023 FOI Services, Inc.
VATT Institute for Economic

2023-3535 05/01/2023 Research
2023-3536 05/01/2023 Copenhagen Trial Unit

University of Marylan,
2023-3537 05/01/2023 Baltimore
Kleinfeld, Kaplan & Becker
2023-3538 05/01/2023 LLP
2023-3539 05/01/2023 JAMAN PARISH-EL 273839
2023-3540 05/01/2023 FOI Services, Inc.
2023-3541 05/01/2023 FOX ROTHSCHILD LLP
2023-3542 05/01/2023 FDAZILLA

2023-3543 05/01/2023 Taiho Oncology Inc.
2023-3544 05/01/2023 TUS
2023-3545 05/01/2023 TUS
2023-3546 05/01/2023 TUS
2023-3547 05/01/2023 TUS
2023-3548 05/01/2023 TUS
2023-3549 05/01/2023 TUS
2023-3550 05/01/2023 TUS
2023-3551 05/01/2023 TUS
2023-3552 05/01/2023 TUS
2023-3553 05/01/2023 TUS
2023-3554 05/01/2023 TUS
2023-3555 05/01/2023 TUS
2023-3556 05/01/2023 TUS
2023-3557 05/01/2023 TUS
2023-3558 05/01/2023 TUS
2023-3559 05/01/2023 TUS
2023-3560 05/01/2023 TUS
2023-3561 05/01/2023 TUS
2023-3562 05/01/2023 TUS
2023-3564 05/01/2023 Bridge Regulatory Affairs, LLC
2023-3565 05/01/2023 Ocular Therapeutix Inc.
2023-3566 05/01/2023 Pour-Rastegar, Terri
2023-3567 05/01/2023 Greenfare Law LLP

WASHINGTON UNIVERSITY
2023-3568 05/01/2023 IN ST. LOUIS
2023-3569 05/01/2023 IN ST. LOUIS
2023-3570 05/01/2023 IN ST. LOUIS
Washington Universtiy in St.

2023-3571 05/01/2023 Louis
2023-3572 05/01/2023 IN ST. LOUIS
2023-3573 05/02/2023 Freelance journalist/author

2023-3574 05/02/2023 The Epoch Times
2023-3575 05/02/2023 Kenneth V. Hemmerle, II, PA
2023-3576 05/02/2023 Morgan & Morgan, P.A.
2023-3577 05/02/2023 Denise Hannigan

2023-3578 05/02/2023 Nomura
PENNSYLVANIA STATE
2023-3579 05/02/2023 UNIVERSITY
2023-3580 05/02/2023 Sheehan and Associates, P.C.

2023-3581 05/02/2023 United Safety Agents, LLC
2023-3582 05/02/2023 REUTERS

2023-3583 05/02/2023 FDAZILLA
2023-3584 05/02/2023 FDAZILLA

2023-3586 05/02/2023 Wexler Surgical, Inc.
2023-3587 05/02/2023 Fresenius Kabi USA
BALYASNY ASSET
2023-3588 05/02/2023 MANAGEMENT
2023-3589 05/02/2023 Souza, Marcio
2023-3590 05/02/2023 Registrar Corp
2023-3591 05/02/2023 DLA PIPER LLP US
2023-3592 05/02/2023 The Epoch Times
2023-3593 05/02/2023 Aeon Respire INC.

2023-3594 05/02/2023 Registrar Corp
2023-3595 05/02/2023 Registrar Corp
2023-3596 05/02/2023 Registrar Corp
2023-3597 05/02/2023 Registrar Corp
2023-3598 05/02/2023 Registrar Corp
2023-3599 05/02/2023 Registrar Corp
2023-3600 05/02/2023 Registrar Corp
2023-3601 05/02/2023 Registrar Corp

2023-3602 05/02/2023 Registrar Corp
BRIGHAM AND WOMEN'S
2023-3603 05/02/2023 HOSPITAL
2023-3604 05/02/2023 ELI LILLY & CO
2023-3605 05/02/2023 Eli Lilly and Company
2023-3606 05/02/2023 Clinuvel Pharmaceuticals Pty

2023-3607 05/02/2023 Xpro associates, LLC
2023-3608 05/02/2023 Dr Ajay Phadke

2023-3609 05/02/2023 Sovish
2023-3610 05/02/2023 Sovish
2023-3611 05/02/2023 Sovish
2023-3612 05/02/2023 The Capitol Forum

University of Missouri School
2023-3614 05/02/2023 of Law Library
2023-3615 05/02/2023 of Law Library
Adamis Pharmaceutical
2023-3616 05/02/2023 Corporation
2023-3617 05/02/2023 POINT72
2023-3618 05/02/2023 Pistevo Law LLC

2023-3619 05/02/2023 Triple Gate Capital
2023-3620 05/02/2023 Harrington Films
Hikma Pharmaceutical USA

2023-3621 05/03/2023 Inc.
2023-3622 05/03/2023 COVINGTON & BURLING LLP
2023-3623 05/03/2023 Pooja Jotwani

Swedish Orphan Biovitrum
2023-3624 05/03/2023 AB (publ)
2023-3625 05/03/2023 BAM
Functional Government
2023-3626 05/03/2023 Initiative
Advancing American
2023-3627 05/03/2023 Freedom
2023-3628 05/03/2023 SIDLEY AUSTIN LLP
2023-3629 05/03/2023 Noah Smith
2023-3630 05/03/2023 Prologue Projects
BALYASNY ASSET
2023-3631 05/03/2023 MANAGEMENT
2023-3632 05/03/2023 FOI Services, Inc.
2023-3633 05/03/2023 FOI Services, Inc.
2023-3634 05/03/2023 CNN
2023-3635 05/03/2023 Prologue Projects

Custom Blends Tobacco and
2023-3636 05/03/2023 News Inc
2023-3637 05/03/2023 Fluidda NV
2023-3638 05/03/2023 Triple Gate Capital
2023-3639 05/03/2023 Rhythm Pharmaceuticals
2023-3640 05/03/2023 Peter Spaulding
2023-3642 05/03/2023 Thompson, Brendan

2023-3643 05/03/2023 Tampa Bay Times
2023-3644 05/03/2023 Tampa Bay Times
2023-3645 05/03/2023 KLS Martin L.P.
2023-3646 05/03/2023 XGen Pharmaceuticals DJB

FAVUS INSTITUTIONAL
2023-3647 05/03/2023 RESEARCH LLC
2023-3648 05/03/2023 Colin Aamot
2023-3649 05/04/2023 FOI Services, Inc.
2023-3650 05/04/2023 FOI Services, Inc.
2023-3651 05/04/2023 FOI Services, Inc.
2023-3652 05/04/2023 FOI Services, Inc.
2023-3653 05/04/2023 FOI Services, Inc.
2023-3654 05/04/2023 FOI Services, Inc.
2023-3655 05/04/2023 FOI Services, Inc.
2023-3656 05/04/2023 GOODWIN PROCTER LLP

2023-3660 05/04/2023 Sovish
2023-3661 05/04/2023 FOI Services, Inc.

2023-3662 05/04/2023 Sovish
2023-3663 05/04/2023 Sovish
2023-3664 05/04/2023 COOLEY LLP
2023-3665 05/04/2023 FOI Services, Inc.
2023-3666 05/04/2023 Emerald Asset Management

2023-3667 05/04/2023 Sovish
2023-3668 05/04/2023 FOI Services, Inc.
2023-3669 05/04/2023 Registrar Corp
2023-3670 05/04/2023 EXPONENT
2023-3671 05/04/2023 EXPONENT
2023-3672 05/04/2023 Registrar Corp
2023-3673 05/04/2023 Registrar Corp

2023-3674 05/04/2023 Arcutis, Inc.
2023-3675 05/04/2023 Registrar Corp
2023-3676 05/04/2023 Registrar Corp
2023-3677 05/04/2023 Registrar Corp

FARALLON CAPITAL
2023-3678 05/04/2023 MANAGEMENT LLC
2023-3679 05/04/2023 THE ASSOCIATED PRESS
2023-3680 05/04/2023 PROPUBLICA
2023-3681 05/04/2023 Registrar Corp
Hyman, Phelps & McNamara,

2023-3682 05/04/2023 P.C.
2023-3683 05/04/2023 Anthony Qi

2023-3684 05/04/2023 Sung Chun Kim, Esq.
2023-3685 05/04/2023 Sung Chun Kim, Esq.
2023-3686 05/04/2023 Sung Chun Kim, Esq.

2023-3687 05/04/2023 Sung Chun Kim, Esq.
2023-3688 05/04/2023 Sung Chun Kim, Esq.

2023-3691 05/04/2023 Sung Chun Kim, Esq.
FARALLON CAPITAL
2023-3693 05/04/2023 MANAGEMENT LLC
Wiley Rein LLP (on behalf of
2023-3694 05/04/2023 Fraser Plastics)
2023-3695 05/04/2023 Foster Law LLC
FARALLON CAPITAL
2023-3696 05/04/2023 MANAGEMENT LLC
FARALLON CAPITAL
2023-3697 05/04/2023 MANAGEMENT LLC
FARALLON CAPITAL
2023-3698 05/04/2023 MANAGEMENT LLC
FARALLON CAPITAL
2023-3699 05/04/2023 MANAGEMENT LLC
FARALLON CAPITAL
2023-3700 05/04/2023 MANAGEMENT LLC
FARALLON CAPITAL
2023-3701 05/04/2023 MANAGEMENT LLC
TIANJIN OKAY
INTERNATIONAL TRADING
2023-3703 05/04/2023 CO.,LTD
2023-3704 05/04/2023 CELLTRION

2023-3705 05/04/2023 KANNER & WHITELEY LLC
2023-3706 05/04/2023 Orson Wang
2023-3707 05/04/2023 Redica Systems
2023-3708 05/04/2023 Redica Systems
2023-3709 05/04/2023 Redica Systems
2023-3710 05/04/2023 MCDERMOTT WILL & EMERY
2023-3711 05/04/2023 Ferrell, Kimberly
2023-3712 05/04/2023 Redica Systems
2023-3713 05/04/2023 Redica Systems
2023-3714 05/04/2023 Redica Systems

2023-3715 05/04/2023 Redica Systems
2023-3716 05/04/2023 Redica Systems
2023-3717 05/04/2023 Redica Systems
2023-3718 05/04/2023 Redica Systems
INTERNATIONAL
CONSORTIUM OF
2023-3719 05/05/2023 INVESTIGATIVE JOURNALISTS
2023-3720 05/05/2023 Vickaryous Law Firm
2023-3721 05/05/2023 Christopher Fallon
2023-3722 05/05/2023 Foster Law LLC
2023-3723 05/05/2023 Dragon's Mouth, LLC

2023-3724 05/05/2023 Morse, Nicole
2023-3725 05/05/2023 Morse, Nicole
2023-3726 05/05/2023 Traditional Medicinals, Inc.


2023-3732 05/05/2023 Bryan Medical Center
FAVUS INSTITUTIONAL
2023-3733 05/05/2023 RESEARCH LLC
BALYASNY ASSET
2023-3734 05/05/2023 MANAGEMENT
BALYASNY ASSET
2023-3735 05/05/2023 MANAGEMENT
BALYASNY ASSET
2023-3736 05/05/2023 MANAGEMENT
2023-3737 05/05/2023 Clarivate Analytics

2023-3739 05/05/2023 Visterra, Inc

Albanese Confectionery
2023-3740 05/05/2023 Group, Inc.
2023-3741 05/05/2023 K&L Gates LLP
2023-3742 05/05/2023 FOI Services, Inc.
2023-3743 05/05/2023 FOI Services, Inc.
2023-3744 05/05/2023 FOI Services, Inc.
2023-3745 05/05/2023 FOI Services, Inc.
2023-3746 05/05/2023 POINT72
2023-3747 05/05/2023 FOI Services, Inc.

2023-3748 05/05/2023 Sovish
2023-3749 05/05/2023 Bhavesh Gandhi
2023-3750 05/05/2023 Schachar, Ira
2023-3751 05/05/2023 Sovish
TIANJIN OKAY
INTERNATIONAL TRADING
2023-3752 05/05/2023 CO.,LTD
2023-3753 05/05/2023 Pooja Jotwani
2023-3754 05/05/2023 Redica Systems
2023-3755 05/05/2023 Redica Systems
2023-3756 05/05/2023 Redica Systems
2023-3757 05/05/2023 Redica Systems
2023-3758 05/05/2023 Redica Systems
2023-3759 05/05/2023 Redica Systems
2023-3760 05/05/2023 Redica Systems
2023-3761 05/05/2023 Redica Systems

2023-3762 05/05/2023 Redica Systems
2023-3763 05/05/2023 Redica Systems
2023-3764 05/05/2023 CHARTER MEDICAL LTD
BALYASNY ASSET
2023-3765 05/05/2023 MANAGEMENT
Greensfelder, Hemker & Gale

2023-3766 05/05/2023 , P.C.
2023-3767 05/05/2023 EXELIXIS
2023-3772 05/05/2023 Y-mAbs Therapeutics

Erasmus University Medical

Center, Rotterdam, The
2023-3781 05/05/2023 Netherlands
2023-3782 05/05/2023 KANNER & WHITELEY LLC

2023-3784 05/08/2023 Hospital
2023-3785 05/08/2023 Pyros Pharmaceuticals, Inc.
Benzodiazepine Information
2023-3786 05/08/2023 Coalition
2023-3787 05/08/2023 Sovish
2023-3788 05/08/2023 FOI Services, Inc.
2023-3789 05/08/2023 FOI Services, Inc.
2023-3790 05/08/2023 United BioSource LLC

NORMMED Medikal Sanayi
2023-3792 05/08/2023 ve Ticaret A.S.
2023-3794 05/08/2023 FOI Services, Inc.
2023-3795 05/08/2023 FOI Services, Inc.

2023-3796 05/08/2023 FOI Services, Inc.
2023-3797 05/08/2023 FOI Services, Inc.

2023-3798 05/08/2023 Hospital
West Pharmaceutical
2023-3799 05/08/2023 Services, Inc.
2023-3800 05/08/2023 Apotex Inc.
2023-3801 05/08/2023 Cook Medical
Quality Solutions and

2023-3802 05/08/2023 Support, LLC
2023-3803 05/08/2023 Cook Medical

2023-3804 05/08/2023 Support, LLC
2023-3805 05/08/2023 ExodusPoint

2023-3806 05/08/2023 Kao, Owen
2023-3807 05/08/2023 REACH24H USA INC.
2023-3808 05/08/2023 FDAZILLA
2023-3809 05/08/2023 Last Week Tonight
2023-3810 05/08/2023 glover, charles
2023-3811 05/08/2023 glover, charles
2023-3812 05/08/2023 glover, charles
2023-3813 05/08/2023 glover, charles
CREDIT SUISSE SECURITIES

2023-3814 05/08/2023 (USA) LLC
2023-3815 05/08/2023 Evans, Shasta
2023-3816 05/08/2023 Evans, Shasta
2023-3817 05/08/2023 Tampa Bay Times
2023-3818 05/08/2023 Columbia Journalism School
2023-3819 05/08/2023 BLOOMBERG NEWS

2023-3820 05/08/2023 ULMER & BERNE LLP
2023-3822 05/08/2023 Redica Systems
2023-3823 05/08/2023 Redica Systems
2023-3824 05/08/2023 Redica Systems
2023-3825 05/08/2023 Redica Systems

2023-3828 05/08/2023 Redica Systems
2023-3829 05/08/2023 Redica Systems

2023-3830 05/08/2023 Redica Systems
2023-3831 05/08/2023 MAGNETAR CAPITAL
2023-3832 05/08/2023 Redica Systems
2023-3833 05/08/2023 Redica Systems
Paul, Weiss, Rifkind, Wharton

2023-3834 05/08/2023 & Garrison LLP
2023-3835 05/08/2023 PROPUBLICA
2023-3836 05/09/2023 Spangler Candy Company
2023-3837 05/09/2023 Ramboll US Consulting

2023-3838 05/09/2023 P.C.

2023-3839 05/09/2023 P.C.
2023-3840 05/09/2023 FOI Services, Inc.
2023-3841 05/09/2023 Sinson Law Group
2023-3842 05/09/2023 FOI Services, Inc.
2023-3843 05/09/2023 P.C.

2023-3845 05/09/2023 FOI Services, Inc.

2023-3846 05/09/2023 of Law Library
2023-3851 05/09/2023 FOI Services, Inc.
2023-3852 05/09/2023 FOI Services, Inc.

2023-3853 05/09/2023 of Law Library
2023-3854 05/09/2023 FOI Services, Inc.
2023-3855 05/09/2023 FOI Services, Inc.

2023-3856 05/09/2023 LATHAM & WATKINS LLP
2023-3859 05/09/2023 Brown & Crouppen, P.C.
PUBLIC SECTOR RETIREMENT
2023-3860 05/09/2023 EDUCATORS
Harvard-MIT Center for
2023-3861 05/09/2023 Regulatory Science
Blood, Hurst & O'Reardon

2023-3862 05/09/2023 LLP
2023-3863 05/09/2023 Support, LLC

2023-3866 05/09/2023 Office YM
2023-3867 05/09/2023 PACIRA BIOSCIENCES

2023-3868 05/09/2023 IEH INC
2023-3870 05/09/2023 Ajanta Pharma USA Inc.
2023-3871 05/09/2023 Stadler, Jane
2023-3872 05/09/2023 Acella Pharmaceuticals

2023-3873 05/09/2023 Redica Systems
2023-3874 05/09/2023 Redica Systems

2023-3875 05/09/2023 FLORIDA HEALTH
2023-3876 05/09/2023 Redica Systems
2023-3877 05/09/2023 Redica Systems
2023-3878 05/09/2023 Redica Systems

2023-3879 05/09/2023 Jakob and Partners LLC
2023-3880 05/09/2023 Redica Systems
2023-3881 05/09/2023 Redica Systems
2023-3882 05/09/2023 PCCA
2023-3883 05/09/2023 Steptoe and Johnson LLP
2023-3884 05/09/2023 Praveen Nautiyal

COLSON HICKS EIDSON LAW
2023-3885 05/09/2023 FIRM
2023-3886 05/10/2023 FOI Services, Inc.
2023-3887 05/10/2023 FOI Services, Inc.
2023-3888 05/10/2023 FOI Services, Inc.
2023-3889 05/10/2023 FOI Services, Inc.
2023-3891 05/10/2023 COGENCY GLOBAL INC.

Sun Pharmaceutical
2023-3892 05/10/2023 Industries Limited
2023-3893 05/10/2023 Ghost Tree Capital
2023-3894 05/10/2023 chonconn
NOVARTIS
PHARMACEUTICALS
2023-3895 05/10/2023 CORPORATION
Humanwell PuraCap
Pharmaceuticals (Wuhan)
2023-3896 05/10/2023 Co., Ltd
2023-3897 05/10/2023 Midway Animal Hospital
2023-3898 05/10/2023 FOI Services, Inc.
2023-3900 05/10/2023 Kemp Jones, LLP

2023-3902 05/10/2023 O'Connor & Partners, PLLC
2023-3903 05/10/2023 Pritzker Hageman, P.A.
2023-3904 05/10/2023 Boston Children's Hospital
2023-3905 05/10/2023 Costello Ginex & Wideikis, PC

2023-3911 05/10/2023 TIME MAGAZINE
2023-3912 05/10/2023 TIME MAGAZINE
2023-3913 05/10/2023 TIME MAGAZINE

2023-3914 05/10/2023 TIME MAGAZINE
2023-3915 05/11/2023 The Lanier Law Firm PLLC
2023-3916 05/11/2023 The Lanier Law Firm PLLC
2023-3917 05/11/2023 XGen Pharmaceuticals DJB
2023-3918 05/11/2023 Gulden Ophthalmics
OHIO STATE UNIVERSITY

2023-3919 05/11/2023 HOSPITALS CLINIC
2023-3920 05/11/2023 Science Corporation
2023-3921 05/11/2023 FOI Services, Inc.
2023-3922 05/11/2023 FOI Services, Inc.
2023-3923 05/11/2023 Zymo Research Corp
2023-3924 05/11/2023 Mtech Group
2023-3925 05/11/2023 Goldblatt + Singer
FARALLON CAPITAL
2023-3927 05/11/2023 MANAGEMENT LLC
FARALLON CAPITAL
2023-3928 05/11/2023 MANAGEMENT LLC
2023-3929 05/11/2023 Morgan, Lewis & Bockius LLP

2023-3936 05/11/2023 FAEGRE & BENSON LLP
2023-3938 05/11/2023 Wuhan Union Hospital
2023-3939 05/11/2023 Redica Systems
2023-3940 05/11/2023 Redica Systems
2023-3941 05/11/2023 Redica Systems
2023-3942 05/11/2023 Redica Systems
2023-3943 05/11/2023 Redica Systems
2023-3944 05/11/2023 Redica Systems
2023-3945 05/11/2023 Redica Systems
2023-3946 05/11/2023 Redica Systems

2023-3947 05/11/2023 Redica Systems
2023-3948 05/11/2023 Redica Systems
2023-3949 05/12/2023 FOI Services, Inc.
2023-3950 05/12/2023 FOI Services, Inc.
2023-3951 05/12/2023 FOI Services, Inc.
2023-3952 05/12/2023 FOI Services, Inc.
2023-3953 05/12/2023 FOI Services, Inc.
2023-3954 05/12/2023 FDA NEWS

2023-3956 05/12/2023 PCCA
2023-3958 05/12/2023 PACIRA BIOSCIENCES
2023-3959 05/12/2023 Registrar Corp

2023-3960 05/12/2023 Registrar Corp
2023-3961 05/12/2023 Registrar Corp
2023-3962 05/12/2023 Registrar Corp

2023-3964 05/12/2023 MS Pharma Inc.
2023-3965 05/12/2023 Registrar Corp
2023-3966 05/12/2023 Registrar Corp
2023-3967 05/12/2023 Registrar Corp
2023-3968 05/12/2023 Burdock Group Consultants
2023-3969 05/12/2023 Registrar Corp

2023-3970 05/12/2023 HOGAN LOVELLS US LLP
2023-3971 05/12/2023 POINT72
Jennifer Cobb University of

2023-3972 05/12/2023 South Carolina
2023-3973 05/12/2023 POINT72

BRIGHAM AND WOMEN'S
2023-3974 05/12/2023 HOSPITAL
BRIGHAM AND WOMEN'S
2023-3975 05/12/2023 HOSPITAL
2023-3976 05/12/2023 DCI INTERNATIONAL
2023-3977 05/12/2023 Scott, Thomas

2023-3978 05/12/2023 Hospital
BioGend Therapeutics Co.,
2023-3979 05/12/2023 Ltd.
2023-3980 05/12/2023 Office YM
Orbicular Pharmaceutical
2023-3981 05/12/2023 Technologies Private Limited
2023-3982 05/12/2023 Baker, William A
Stanford University (Maya
2023-3983 05/12/2023 Durvasula)
2023-3984 05/12/2023 Corvex Management LP
2023-3985 05/12/2023 The Perishable Specialist Inc.
2023-3986 05/12/2023 Edwards Beightol, LLC
2023-3987 05/12/2023 Sankei Co., Ltd.
2023-3988 05/12/2023 THE WALL STREET JOURNAL
2023-3989 05/12/2023 FOI Services, Inc.
2023-3990 05/12/2023 FOI Services, Inc.
2023-3991 05/12/2023 FOI Services, Inc.

2023-3992 05/15/2023 FDAZILLA
2023-3993 05/15/2023 FDAZILLA
2023-3994 05/15/2023 FDAZILLA
2023-3995 05/15/2023 Office YM
Nova Southeastern
2023-3996 05/15/2023 University
2023-3997 05/15/2023 BIOGEN
2023-3998 05/15/2023 Mekary, Souha
2023-3999 05/15/2023 Wuhan Union Hospital

2023-4001 05/15/2023 of Law Library
2023-4002 05/15/2023 Leading Pharma, LLC
2023-4003 05/15/2023 FOI Services, Inc.
2023-4004 05/15/2023 Palmetto Bay
2023-4005 05/15/2023 Axis Clinicals.LLC
2023-4006 05/15/2023 Patel, Amar
2023-4007 05/15/2023 FDAZILLA
Erasmus University Medical

Center, Rotterdam, The
2023-4008 05/15/2023 Netherlands
2023-4009 05/15/2023 WSHU/NPR

BALYASNY ASSET
2023-4010 05/15/2023 MANAGEMENT
2023-4012 05/15/2023 BLOOMBERG NEWS

2023-4013 05/15/2023 William Drake
Ballard Spahr LLP on behalf
2023-4014 05/15/2023 of client
Ballard Spahr LLP on behalf
2023-4015 05/15/2023 of client
2023-4016 05/15/2023 Regunalys LLC
Taiwan Liposome Company
2023-4017 05/15/2023 Ltd.
Taiwan Liposome Company,
2023-4018 05/15/2023 Ltd
Taiwan Liposome Company,
2023-4019 05/15/2023 Ltd.
2023-4020 05/15/2023 Gluten Free

Kleinfeld, Watchdog,
Kaplan LLC
& Becker
2023-4021 05/15/2023 LLP
2023-4022 05/15/2023 BQ Prime
2023-4023 05/15/2023 Redica Systems
2023-4024 05/15/2023 Redica Systems
2023-4025 05/15/2023 Redica Systems
2023-4026 05/15/2023 Redica Systems

2023-4027 05/15/2023 Redica Systems
2023-4028 05/15/2023 Redica Systems
BALYASNY ASSET
2023-4029 05/15/2023 MANAGEMENT
Zydus Pharmaceuticals USA
2023-4030 05/15/2023 Inc
UNIVERSITY OF
WASHINGTON SCHOOL OF
2023-4031 05/15/2023 MEDICINE
2023-4032 05/15/2023 Horizon Therapeutics plc
2023-4033 05/16/2023 Registrar Corp
2023-4034 05/16/2023 Registrar Corp
2023-4035 05/16/2023 Registrar Corp
2023-4036 05/16/2023 Registrar Corp

2023-4037 05/16/2023 Registrar Corp
2023-4038 05/16/2023 Registrar Corp
2023-4040 05/16/2023 Registrar Corp

2023-4041 05/16/2023 FOI Services, Inc.

2023-4045 05/16/2023 FOI Services, Inc.
2023-4046 05/16/2023 Tandem Diabetes Care, Inc.
2023-4047 05/16/2023 Horizon Therapeutics, LLC

Premier Dental Products
2023-4048 05/16/2023 Company
2023-4049 05/16/2023 knoell USA LLC

2023-4051 05/16/2023 GREENBERG TRAURIG LLP
2023-4052 05/16/2023 Registrar Corp
2023-4055 05/16/2023 Nomura
2023-4056 05/16/2023 Nomura
KLEINFELD KAPLAN &

2023-4057 05/16/2023 BECKER
2023-4058 05/16/2023 justin romanowich

2023-4060 05/16/2023 N/A
VVV AND SONS EDIBLE OILS

2023-4061 05/16/2023 LTD
2023-4062 05/16/2023 Corvex Management LP

2023-4063 05/16/2023 P.C.

2023-4065 05/16/2023 FOI Services, Inc.
Council for Responsible

2023-4066 05/16/2023 Nutrtion
2023-4067 05/16/2023 Regunalys LLC
2023-4068 05/16/2023 Regunalys LLC
Clarivate Analytics (France)

2023-4069 05/16/2023 SAS

2023-4070 05/16/2023 SAS

2023-4071 05/16/2023 SAS
2023-4072 05/16/2023 SAS
2023-4073 05/16/2023 FOI Services, Inc.
2023-4074 05/16/2023 FOI Services, Inc.
2023-4075 05/16/2023 FOI Services, Inc.
2023-4076 05/16/2023 FOI Services, Inc.
2023-4077 05/16/2023 FOI Services, Inc.

2023-4078 05/16/2023 NC STATE UNIVERSITY
2023-4079 05/16/2023 Bustamante Brokers
2023-4080 05/16/2023 Bustamante Brokers
2023-4081 05/16/2023 Bustamante Brokerage

2023-4082 05/16/2023 Kramer Laboratories
2023-4083 05/16/2023 Cogency Global Inc

Maxwell Biosiences, Inc./Att.
2023-4084 05/17/2023 Dilday
Sun Pharmaceutical

2023-4087 05/17/2023 FOIA GROUP INC
Sun Pharmaceutical
2023-4089 05/17/2023 Redica Systems

Mylan Laboratories Ltd, a
2023-4090 05/17/2023 Viatris Company
Mylan Laboratories Ltd, a
2023-4091 05/17/2023 Viatris Company
2023-4092 05/17/2023 GC Biopharma corporation
SHENZHEN TPH
2023-4093 05/17/2023 TECHNOLOGY CO., LTD.
2023-4094 05/17/2023 Nose Slap LLC
2023-4095 05/17/2023 Redica Systems
2023-4096 05/17/2023 Redica Systems
2023-4097 05/17/2023 Redica Systems
2023-4098 05/17/2023 Redica Systems

2023-4099 05/17/2023 Redica Systems
2023-4100 05/17/2023 Redica Systems
2023-4101 05/17/2023 Redica Systems
2023-4102 05/17/2023 Redica Systems
2023-4103 05/17/2023 Redica Systems
2023-4104 05/17/2023 Duty, Harry
2023-4105 05/17/2023 Duty, Harry
2023-4106 05/17/2023 Duty, Harry
BAKER DONELSON BEARMAN

2023-4107 05/17/2023 CALDWELL & BERKOWITZ PC
2023-4108 05/17/2023 Sovish
2023-4109 05/17/2023 Judicial Watch, Inc.
2023-4111 05/17/2023 McDevitt & Cobb, P.C.

2023-4112 05/17/2023 Registrar Corp
2023-4113 05/17/2023 Registrar Corp
2023-4114 05/17/2023 Registrar Corp
2023-4115 05/17/2023 FOIA Request Services, LLC

2023-4117 05/17/2023 Brown & Crouppen, PC
2023-4118 05/17/2023 THE BLACK VAULT, INC
2023-4119 05/17/2023 COZEN O'CONNOR

2023-4121 05/17/2023 Sparrow Acoustics Inc.
2023-4122 05/17/2023 Turner Construction
2023-4123 05/18/2023 Registrar Corp
2023-4124 05/18/2023 Registrar Corp

2023-4125 05/18/2023 Registrar Corp
2023-4126 05/18/2023 Registrar Corp
2023-4127 05/18/2023 Registrar Corp
2023-4128 05/18/2023 Registrar Corp
2023-4129 05/18/2023 Registrar Corp
2023-4130 05/18/2023 Registrar Corp
2023-4131 05/18/2023 Registrar Corp

2023-4132 05/18/2023 Tela Bio
2023-4133 05/18/2023 Hien Lieu
2023-4134 05/18/2023 Redica Systems
2023-4135 05/18/2023 Redica Systems

2023-4136 05/18/2023 Redica Systems
2023-4137 05/18/2023 Redica Systems
2023-4138 05/18/2023 Redica Systems
2023-4139 05/18/2023 Redica Systems
2023-4140 05/18/2023 Redica Systems
2023-4141 05/18/2023 Aurobindo Pharma USA Inc.
2023-4142 05/18/2023 Registrar Corp
2023-4143 05/18/2023 Aurobindo Pharma USA Inc.
2023-4144 05/18/2023 Registrar Corp
2023-4145 05/18/2023 K&L Gates LLP

2023-4146 05/18/2023 of Law Library
2023-4147 05/18/2023 of Law Library
2023-4148 05/18/2023 Redica Systems
2023-4149 05/18/2023 Redica Systems
2023-4150 05/18/2023 Redica Systems
2023-4151 05/18/2023 Redica Systems
Functional Government
2023-4152 05/18/2023 Initiative


2023-4163 05/18/2023 FOI Services, Inc.
2023-4164 05/18/2023 Medytox Inc.
2023-4165 05/18/2023 Prometheus Biosciences, Inc.
2023-4166 05/18/2023 Tufts Security & Privacy Lab
2023-4167 05/18/2023 wu, can
2023-4168 05/18/2023 Advitech SA
2023-4169 05/18/2023 MAHONEY, PATRICK E
2023-4170 05/18/2023 FOI Services, Inc.

2023-4172 05/18/2023 Keller and Heckman LLP
RUBRIC CAPITAL
2023-4173 05/18/2023 MANAGEMENT LLC
Minaris Regenerative
2023-4174 05/18/2023 Medicine, LLC
2023-4175 05/18/2023 Liu, Jinglan
2023-4176 05/18/2023 Registrar Corp
2023-4177 05/18/2023 Registrar Corp

2023-4178 05/18/2023 Tela Bio
Minaris Regenerative
2023-4179 05/18/2023 Medicine, LLC
2023-4180 05/18/2023 Registrar Corp
2023-4181 05/18/2023 Registrar Corp
2023-4182 05/18/2023 Registrar Corp
2023-4183 05/18/2023 Registrar Corp

2023-4184 05/18/2023 Registrar Corp
2023-4185 05/18/2023 Registrar Corp
2023-4186 05/18/2023 Registrar Corp
2023-4187 05/18/2023 Registrar Corp
2023-4188 05/18/2023 Pistevo Law LLC

2023-4190 05/19/2023 Sparrow Acoustics Inc.
SHEFFIELD
2023-4191 05/19/2023 PHARMACEUTICALS INC
2023-4192 05/19/2023 ALK Abello INC
2023-4193 05/19/2023 Redica Systems
2023-4194 05/19/2023 Redica Systems
2023-4195 05/19/2023 Redica Systems
2023-4196 05/19/2023 Redica Systems

2023-4197 05/19/2023 Redica Systems
2023-4198 05/19/2023 Redica Systems
2023-4199 05/19/2023 Redica Systems
2023-4200 05/19/2023 Redica Systems
2023-4201 05/19/2023 Redica Systems

Sun Pharmaceutical
SHEFFIELD
2023-4205 05/19/2023 Redica Systems
2023-4206 05/19/2023 Public Health Law Center

2023-4207 05/19/2023 The Epoch Times
2023-4208 05/19/2023 N/A
2023-4209 05/19/2023 KFF Health News

2023-4211 05/19/2023 FOI Services, Inc.
2023-4212 05/19/2023 THOMSON REUTERS
2023-4213 05/19/2023 Dr. Karen Hatwell
2023-4214 05/19/2023 Animal Partisan
2023-4217 05/19/2023 Registrar Corp
2023-4218 05/19/2023 Registrar Corp

2023-4219 05/19/2023 Registrar Corp
2023-4220 05/19/2023 Registrar Corp
2023-4221 05/19/2023 Registrar Corp
2023-4222 05/19/2023 Registrar Corp
2023-4223 05/19/2023 Registrar Corp
2023-4224 05/19/2023 Registrar Corp
2023-4225 05/19/2023 Registrar Corp
2023-4226 05/19/2023 Registrar Corp
2023-4227 05/19/2023 Purolite, An Ecolab Company

2023-4228 05/19/2023 Inc
2023-4229 05/19/2023 Farmer Brothers
2023-4230 05/22/2023 Redica Systems
2023-4235 05/22/2023 Virbac AH, Inc
2023-4236 05/22/2023 SCIENCE MAGAZINE
2023-4240 05/22/2023 BackStop Neural, Inc.

2023-4241 05/22/2023 FOI Services, Inc.
2023-4242 05/22/2023 FOI Services, Inc.
2023-4243 05/22/2023 FOI Services, Inc.

FAVUS INSTITUTIONAL
2023-4245 05/22/2023 RESEARCH LLC
2023-4246 05/22/2023 Redica Systems
2023-4247 05/22/2023 Redica Systems
2023-4248 05/22/2023 Redica Systems
2023-4249 05/22/2023 Redica Systems
2023-4250 05/22/2023 Redica Systems
2023-4251 05/22/2023 Redica Systems
2023-4252 05/22/2023 Redica Systems
2023-4253 05/22/2023 Redica Systems


2023-4256 05/22/2023 FDAZILLA
2023-4257 05/22/2023 FDAZILLA
2023-4258 05/22/2023 Dr Ajay Phadke
2023-4259 05/22/2023 BLOOMBERG NEWS
2023-4260 05/22/2023 glover, charles
2023-4261 05/22/2023 glover, charles
2023-4262 05/22/2023 myself
Humanwell PuraCap
Pharmaceuticals (Wuhan) Co
2023-4263 05/22/2023 Ltd.
2023-4264 05/22/2023 Regunalys LLC
Womble Bond Dickinson (US)
2023-4265 05/22/2023 LLP
Hospital of the University of

Pennsylvania, Dept of
2023-4267 05/22/2023 Neurology
Hospital of the University of
Pennsylvania, Dept of
2023-4268 05/22/2023 Neurology
Bernstein Litowitz Berger &

2023-4270 05/22/2023 Grossmann LLP
2023-4271 05/22/2023 ByHeart
2023-4272 05/22/2023 CPKelco
2023-4274 05/22/2023 ByHeart
2023-4275 05/22/2023 ByHeart

2023-4276 05/22/2023 Cogency Global Inc

2023-4278 05/22/2023 CNY FERTILITY CENTER
2023-4279 05/22/2023 CNY FERTILITY CENTER
2023-4280 05/22/2023 PARKER STANBURY LLP
2023-4292 05/22/2023 NorthStar Healthcare UC
2023-4293 05/22/2023 POINT72
2023-4294 05/22/2023 Registrar Corp
2023-4295 05/22/2023 Registrar Corp
2023-4296 05/22/2023 Registrar Corp
2023-4297 05/22/2023 Registrar Corp

2023-4298 05/22/2023 Registrar Corp
2023-4299 05/22/2023 Red Summit Consulting

2023-4300 05/22/2023 Melton, Donavan
2023-4301 05/22/2023 Judy Snow and Associates
2023-4302 05/22/2023 Judy Snow and Associates
2023-4303 05/22/2023 ByHeart
2023-4315 05/22/2023 Regunalys LLC

2023-4316 05/23/2023 SAS
2023-4317 05/23/2023 Bernstein, Christina
2023-4318 05/23/2023 Redica Systems
2023-4319 05/23/2023 Redica Systems

2023-4320 05/23/2023 Redica Systems
2023-4322 05/23/2023 Redica Systems
2023-4323 05/23/2023 Redica Systems
2023-4324 05/23/2023 Redica Systems
2023-4325 05/23/2023 Redica Systems
2023-4326 05/23/2023 CINCINNATI ENQUIRER
2023-4327 05/23/2023 Redica Systems
2023-4328 05/23/2023 Redica Systems
2023-4329 05/23/2023 Redica Systems
2023-4330 05/23/2023 Redica Systems

2023-4331 05/23/2023 Xtant Medical Holdings, Inc.
2023-4332 05/23/2023 Redica Systems

2023-4333 05/23/2023 FOI Services, Inc.
2023-4334 05/23/2023 FOI Services, Inc.

2023-4335 05/23/2023 P.C.
2023-4336 05/23/2023 Inc

2023-4339 05/23/2023 FOI Services, Inc.
2023-4341 05/23/2023 FOI Services, Inc.
2023-4343 05/23/2023 CLARIVATE ANALYTICS US LLC

2023-4347 05/23/2023 Simple Path LLC
2023-4349 05/23/2023 DMI Research
2023-4350 05/23/2023 Stinson LLP
2023-4351 05/23/2023 Registrar Corp
2023-4352 05/23/2023 Registrar Corp
2023-4353 05/23/2023 Registrar Corp
2023-4354 05/23/2023 Registrar Corp
2023-4355 05/23/2023 Registrar Corp
Womble Bond Dickinson (US)

2023-4356 05/23/2023 LLP
Florida Agency for Health

2023-4357 05/23/2023 Care Administration
2023-4358 05/23/2023 SAS

2023-4359 05/23/2023 SAS

2023-4360 05/23/2023 SAS
2023-4366 05/23/2023 Abrams, David

ANDREW KICKING HORSE
2023-4367 05/23/2023 MCCARTER D-92951
2023-4368 05/23/2023 STEPHEN VERCHINSKI
2023-4369 05/24/2023 Harvest Dental Products, LLC

2023-4370 05/24/2023 Inc
SHEFFIELD
2023-4372 05/24/2023 APOTEX CORP.

2023-4373 05/24/2023 Inc
2023-4374 05/24/2023 Redica Systems
2023-4375 05/24/2023 Redica Systems
2023-4376 05/24/2023 Redica Systems
2023-4377 05/24/2023 Redica Systems

2023-4378 05/24/2023 Alfred Smith
2023-4379 05/24/2023 Regunalys LLC
2023-4380 05/24/2023 Regunalys LLC
2023-4381 05/24/2023 Harding Mazzotti LLP
2023-4382 05/24/2023 Registrar Corp
2023-4383 05/24/2023 Registrar Corp

2023-4384 05/24/2023 Registrar Corp
2023-4385 05/24/2023 Registrar Corp
2023-4386 05/24/2023 Registrar Corp
2023-4387 05/24/2023 Registrar Corp
2023-4388 05/24/2023 Registrar Corp
2023-4389 05/24/2023 Registrar Corp
POINT72 ASSET
2023-4390 05/24/2023 MANAGEMENT LP
2023-4391 05/24/2023 BROOKS LIFE SCIENCES INC.
2023-4392 05/24/2023 Micro Labs USA, Inc.
2023-4393 05/24/2023 Saxton & Stump, LLC

2023-4394 05/24/2023 Garsow, Michael R
2023-4395 05/24/2023 Patel, Amar
2023-4396 05/24/2023 Prolacta Bioscience, Inc.
2023-4397 05/24/2023 FOI Services, Inc.
2023-4398 05/24/2023 FOI Services, Inc.
2023-4399 05/24/2023 FOI Services, Inc.
2023-4400 05/24/2023 FOI Services, Inc.
2023-4401 05/24/2023 FOI Services, Inc.
2023-4402 05/24/2023 Redica Systems
2023-4403 05/24/2023 Redica Systems
2023-4404 05/24/2023 Redica Systems
2023-4405 05/24/2023 Redica Systems
2023-4406 05/24/2023 Redica Systems

2023-4407 05/24/2023 Redica Systems
2023-4408 05/24/2023 Registrar Corp
2023-4409 05/24/2023 Registrar Corp
2023-4410 05/24/2023 Garonit Pharmaceutical, Inc.
2023-4411 05/24/2023 TCG X

2023-4412 05/24/2023 Brock, Wanda
2023-4413 05/24/2023 Brock, Wanda
2023-4414 05/24/2023 PETA FOUNDATION
2023-4417 05/24/2023 STAT News

Greenan, Peffer, Sallander &
2023-4418 05/24/2023 Lally, LLP
BALYASNY ASSET
2023-4419 05/24/2023 MANAGEMENT
BALYASNY ASSET
2023-4420 05/24/2023 MANAGEMENT
BALYASNY ASSET
2023-4421 05/24/2023 MANAGEMENT
BALYASNY ASSET
2023-4422 05/24/2023 MANAGEMENT
2023-4423 05/24/2023 Herb Pharm

Quinn Emanuel Urquhart &
2023-4424 05/24/2023 Sullivan, LLP
2023-4428 05/24/2023 Solutech MG

2023-4429 05/24/2023 POINT72
2023-4430 05/24/2023 Byrd, Precious
2023-4431 05/25/2023 NMIMS Mumbai

2023-4432 05/25/2023 Thrombolex, Inc.
2023-4433 05/25/2023 Kelehua Capital Management

GARWIN GERSTEIN & FISHER
2023-4434 05/25/2023 LLP
2023-4435 05/25/2023 Harmony Biosciences

SHEFFIELD
2023-4437 05/25/2023 POINT72
2023-4438 05/25/2023 Xencor Inc

2023-4439 05/25/2023 FOI Services, Inc.
2023-4440 05/25/2023 DRE Medical Group, INC
2023-4441 05/25/2023 Integer, Lake Region Medical
2023-4442 05/25/2023 Xencor Inc

2023-4443 05/25/2023 FOI Services, Inc.
2023-4444 05/25/2023 Griffith, Thomas K
2023-4445 05/25/2023 Lupin Pharmaceuticals, Inc.

BALYASNY ASSET
2023-4446 05/25/2023 MANAGEMENT
BALYASNY ASSET
2023-4447 05/25/2023 MANAGEMENT
BALYASNY ASSET
2023-4448 05/25/2023 MANAGEMENT
2023-4449 05/25/2023 APOTEX CORP.
2023-4451 05/25/2023 WCPO-TV
2023-4452 05/25/2023 Union Agener Inc

THOMSON REUTERS COURT
2023-4453 05/25/2023 EXPRESS
2023-4455 05/25/2023 Jonathan Klick

2023-4456 05/25/2023 Access Dental Lab
2023-4457 05/25/2023 of Law Library
2023-4458 05/25/2023 Harvest Valley Bakery, Inc

2023-4459 05/25/2023 Richard Parkes

2023-4462 05/26/2023 OptMed
2023-4463 05/26/2023 Endocision Technologies Inc.
2023-4464 05/26/2023 TUFTS UNIVERSITY
2023-4465 05/26/2023 QuVa Pharma, Inc.
2023-4466 05/26/2023 Bayer Medical Care Inc.

The Atlanta Journal-

2023-4468 05/26/2023 Constitution
2023-4469 05/26/2023 Cannabis Wire
2023-4470 05/26/2023 PROPHARMA GROUP

2023-4471 05/26/2023 Inc
Robbins Geller Rudman &

2023-4472 05/26/2023 Dowd LLP
2023-4473 05/26/2023 Andrew Sheinfeld
2023-4474 05/26/2023 Andrew Sheinfeld

Preferred Regulatory
2023-4475 05/26/2023 Consulting Inc.
2023-4477 05/26/2023 FOI Services, Inc.
2023-4478 05/26/2023 Sciecure Pharma Inc.

2023-4479 05/26/2023 Consulting Inc.
2023-4480 05/26/2023 Consulting Inc.
2023-4481 05/26/2023 Consulting Inc.
2023-4482 05/26/2023 Redica Systems
2023-4483 05/26/2023 Redica Systems
2023-4484 05/26/2023 Redica Systems

2023-4485 05/26/2023 Redica Systems
2023-4486 05/26/2023 Redica Systems
2023-4487 05/26/2023 Redica Systems
2023-4488 05/26/2023 Redica Systems
2023-4489 05/26/2023 Redica Systems
2023-4490 05/26/2023 Redica Systems
2023-4491 05/26/2023 Redica Systems

2023-4495 05/30/2023 CNBC
2023-4497 05/30/2023 UNIVERSITY OF FLORIDA
2023-4498 05/30/2023 GEORGE MASON UNIVERSITY

2023-4499 05/30/2023 Universty of Parma
BALYASNY ASSET
2023-4500 05/30/2023 MANAGEMENT
2023-4501 05/30/2023 Anderson, Petal M
2023-4503 05/30/2023 Harvest Valley Bakery, Inc
2023-4504 05/30/2023 Hallux Inc

2023-4505 05/30/2023 Mtech Group
BALYASNY ASSET
2023-4506 05/30/2023 MANAGEMENT
2023-4507 05/30/2023 FOI Services, Inc.
2023-4508 05/30/2023 FOI Services, Inc.
2023-4509 05/30/2023 Chipshot
BALYASNY ASSET
2023-4510 05/30/2023 MANAGEMENT
2023-4511 05/30/2023 QSITE
2023-4512 05/30/2023 FDAZILLA
2023-4513 05/30/2023 Madison Avenue Partners
2023-4514 05/30/2023 United Safety Agents LLC

2023-4515 05/30/2023 SAS

2023-4516 05/30/2023 SAS
2023-4517 05/30/2023 FDAZILLA
2023-4518 05/30/2023 FDAZILLA

2023-4519 05/30/2023 SAS

2023-4520 05/30/2023 SAS

2023-4521 05/30/2023 SAS

2023-4522 05/30/2023 SAS

2023-4523 05/30/2023 SAS

2023-4524 05/30/2023 SAS

2023-4525 05/30/2023 SAS

2023-4526 05/30/2023 SAS

2023-4527 05/30/2023 SAS
2023-4528 05/30/2023 COZEN O'CONNOR
2023-4529 05/30/2023 Arnold & Porter LLP
2023-4530 05/30/2023 Panther Healthcare USA

2023-4531 05/31/2023 Vratislav Svoboda
2023-4532 05/31/2023 Andrew Richards
2023-4533 05/31/2023 HUSCH BLACKWELL LLP

2023-4537 05/31/2023 P.C.
2023-4538 05/31/2023 POINT72
2023-4539 05/31/2023 Michael Best & Friedrich LLP
2023-4540 05/31/2023 Registrar Corp
Sanchez Daniels & Hoffman

2023-4541 05/31/2023 LLP
BALYASNY ASSET
2023-4542 05/31/2023 MANAGEMENT
2023-4543 05/31/2023 FOI Services, Inc.

2023-4544 05/31/2023 FOI Services, Inc.
2023-4545 05/31/2023 FOI Services, Inc.
2023-4546 05/31/2023 FOI Services, Inc.
2023-4547 05/31/2023 SCA Pharmaceuticals, LLC
2023-4550 05/31/2023 New Universe Food, LLC

2023-4551 05/31/2023 TECHTEAM LLC
Subject REQ Closed Date
2023-1088, 2023-1097, 2023-1098, 2023-1119, 2023-1128 05/03/2023
1. All reports of adverse events and/or reactions dog and/or cats have had to dog and cat food and dog and cat treats from 08.01.2022-
03.31.2023. a. Please include the type of animal, the reaction, the brand name and the product name of the food item to which the dog
or cat reacted, the symptoms displayed and the outcome, if available. etc 05/04/2023
I am requesting the records from FDA-CVM for the copy of what they recognize as the AAFCO ingredient "bone meal" 05/26/2023
Thank you in advance for your help in retrieving data (case report and event/problem narrative). We are investigating adverse events
reported related to CBD use. 05/04/2023
Sintetica herewith requests Summary Basis of Approval (Review) Package for INFORLIFE Products NOREPINEPHRINE BITARTRATE IN 0.9%
SODIUM CHLORIDEproduct (NDA# 215700). Sintetica is specifically looking for Administrative Documents and Correspondence,
Summary Review, Medical Review, Chemistry Review, Pharmacology Review, Clinical Pharmacology Biopharmaceutics Review, etc 05/04/2023
Attn: CBER. Copy of the disclosable portions of the following Untitled Letters: 03/05/2010 to CSL Behring (FEI 3000215763); 03/26/2010
to OMRIX Biopharmaceuticals (FEI 3003183625); 06/24/2011 to Novartis Institute for Biomedica (FEI 3005226114); 09/01/2011 to
OMRIX Biopharmaceuticals (FEI 3003183625); and 02/27/2018 to CSL Behring (FEI 3000215763). 05/08/2023
1. Any and all letters, emails and other communications between the FDA and Y-mAbs and/or Memorial Sloan Kettering Cancer
Center (“MSKCC”), as well as any documents, memoranda or notes concerning communications between the FDA and Y-mAbs and/or
MSKCC concerning 131I-omburtamab, including but not limited to communications on or about the following dates (see list below) as
identified in Table 2 and Table 3 of the FDA Briefing Document for BLA 761176 for the Oncologic Drugs Advisory Committee Meeting on
October 28, 2022 etc 05/11/2023
MedWatch reports for 12 molnupiravir cases: 21986261, 22019976, 22019932, 22053263, 21986261, 22088413, 22134908, 22129606,
22147506, 22212404, 22206336, 21986261 05/19/2023
I am an investment professional at an asset management firm and would like to requests all form 483s issued in 2023 for the following
facility: UCB Pharma SA Chemin du Foriest Braine-l’Alleud, Belgium, 1420 FEI #: 3003909356 If there are no form 483s found, please
confirm whether this facility has been inspected in 2023. If possible delivery in electronic format is requested. 05/19/2023
- New Drug Applications / Biologics License Application for Mounjaro / Ozempic / Wegovy / Trulicity / Saxenda / Victoza
05/05/2023
Please see my attached PDF for the information that I am looking for. I am looking for detailed information around Teva/Actavis
Generics' generic version of the drug Prednisone. I would like information from the first year that Teva/Actavis Generics started selling
Prednisone until today. 05/05/2023
The "Request Receipt Date" for Apellis Pharmaceuticals' Breakthrough Therapy Request for its product, pegcetacoplan (aka APL-2), for
the treatment of geographic atrophy. Also the date of signature by the FDA "Reviewer", "Team Leader", and/or "Division Director" on
the corresponding "CDER Breakthrough Therapy Designation Determination Review Template."
Form 483 for Catalent 7555 Harmans Road, Harmans, MD 21077 05/02/2023
Form 483 for Thermo Fisher Scientific, 168 3rd Ave, Waltham, MA 02451 05/02/2023
We would like to FOIA FAERS case report number: 22134131 for Apellis Pharmaceuticals 05/19/2023
I am an investment professional and this is a request under the Freedom of Information Act. I would like to request an adverse report
for Syfovre (pegcetacoplan injection) in PDF and Excel. If possible, we would prefer materials to be emailed directly to
quinn.lin@point72.com or mailed via USB stick. Thank you! 05/19/2023
I am an investment professional and this is a request under the Freedom of Information Act. I would like to request the detailed adverse
event report for Syfovre (pegcetacoplan injection) case # 21766657 in Excel and PDF. Would be great if we could get the materials
emailed to quinn.lin@point72.com. Thanks! 05/19/2023
CDER Divisional INDs, FT, BTD Requests
FDA FAERS reports on pegcetacoplan (brand name SYFOVRE). Please include full narrative of events where possible. Please look for
events under either name. If possible, please email the results to the requesting email (or send via USB stick). 05/19/2023
Copy of the disclosable portions of the 483 for the 03/2023 inspection of Alvotech, located in Reykjavik, Iceland. Please note this
inspection relates to human drugs. 05/01/2023
FDA FAERS reports on pegcetacoplan (brand name SYFOVRE). Please search the database for both drug names. Please provide the full
detailed case reports for events that have occurred in 2023 in addition to summary excel. Providing the results via email correspondence
is preferred. 05/19/2023
Form 483 and accompanying records for inspection conducted from Dec. 5 to Dec. 9, 2022 at BioMarin Pharmaceutical Inc. (FEI:
3004079983; MHRA Site ID: 11593).
Please provide a detailed individual case report for FDA Case # 22134131 for product Syfovre (pegcetacoplan). 05/19/2023
Under the Freedom of Information Act, I would like to request a copy of the original approval package for NDA 012142 – Cytoxan, serial
0000, approval date 11/16/1959, which was a priority approval, Type 1 - New Molecular Entity. 05/19/2023
Under the Freedom of Information Act, I would like to request a copy of the original approval package for NDA 020038, Fludarabine
Phosphate Injection, serial 0000, approval date 04/18/1991, which was a priority approval, Type 1 - New Molecular Entity. 05/19/2023
Form 483 issued with 3 observations following inspection of Ipca Laboratories Limited's formulations manufacturing unit situated at
Piparia (Silvassa), India, between 18th April, 2023 to 26th April, 2023. 05/15/2023
Request for form 483 with respect to recent USFDA inspection at Pipariya, Silvasa, (FEI: 3005977675) site of Ipca Laboratories. Thanking
you in anticipation 05/19/2023
Please provide the following disclosable 483s, 483 Responses in electronic format (.pdf)
conducted since January 1, 2018 related to Mac-Chem, located in India 05/19/2023
We are writing to request, via FOIA, the full case report document for case #22134131 in the FDA FAERS database. 05/19/2023
We are writing to request via FOIA, the database of FDA FAERS reports on pegcetacoplan (brand name SYFOVRE). 05/19/2023
Request you to share a copy of the Form-483 issued on IPCA Laboratories' formulations manufacturing unit situated at Piparia (Silvassa)
from 18 April, 2023 to 26 April, 2023. Three observations were identified. 05/19/2023
Would like access to the form 483 issued by the US FDA to Indoco Remedies with four observations for their Goa plant II and III for
which inspection was conducted from 20th February, 2023 to 28th February, 2023. 05/19/2023
All email communications from December 30, 2020 through the date of the search sent or received by Doran Fink, Julia Tierney, Martina
Varnado, and/or Wanda Russ that include the words (“Maddie” or “Madeline”) and (“deGaray” or “de Garay”) in the body, subject line,
and/or any other part of the email.
See attached declaration and corresponding documents regarding the waiver of privacy rights and consent to release responsive
records. (Attachment A.)
Copies of Form 483s issued by the CDER Office in February 1-28, 2023. 05/19/2023
Copies of Form 483s issued by the CDER Complex Office in February 1-28, 2023.
Copies of Form 483s issued by the CBER Office in February 1-28, 2023.
Copies of Form 483s issued by the CDRH Office in February 1-28, 2023.
All communications sent or received by John Concato, David Money, Patricia Bright and/or Peter Marks, to or from any individual at
International Coalition of Medicines Regulatory Authority (“ICMRA”) and/or anyone with an “@ema.europe.eu” domain name, from
January 1, 2021 through December 31, 2021.
All email communications from January 1, 2021 through the date of the search sent or received by Janet Woodcock, Peter Marks,
Marion Gruber, Philip Krause, Doran Fink, and/or Paul Richards that include the term “12701222” in the body, subject line, and/or any
other part of the email.
See attached declaration and corresponding documents regarding the waiver of privacy rights and consent to release responsive
records.
Under the Freedom of Information Act, 5 U.S.C .§ 552, I am requesting to obtain information regarding the following record: I am
requesting a copy of the REMS review associated with the approval of the supplemental NDA S-023 for Opsumit (NDA 204410), which
was approved on February 1, 2023. I approve fees up to $50 before being notified. 05/19/2023
All records titled, labeled, or otherwise identified to be an “Annual Status Report of Postmarketing Study Requirement/Commitments”
submitted to the FDA, to date, by BioNTech and/or Pfizer.
To support our registration filing of DAXXIFY (BLA 761127) in Australia (TGA), Revance Therapeutics, Inc. (BLA holder) respectfully
requests the unredacted copies of the FDA Application Review Files for DAXXIFY. • Summary Review • Risk Evaluation and Mitigation
Strategy (REMS) • Officer/Employee List • Office Director Memo • Cross Discipline Team Leader Review etc 05/11/2023
K181153 - 510(k) for ICEfx Cryoablation System
Copy of the disclosable portions of the complete FDA response for File Number 2018-475. 05/08/2023
I would like to request any responsive records provided in response to FOIA #2020-1838, which was filed on March 2, 2020. 05/08/2023
Hello, I'd like all responsive records issued in response to FOIA #2016-6080, which was filed on 7/25/2016. 05/08/2023
Copy of the disclosable portions of the complete FDA responses for the following File Numbers: 2022-6140, 2022-6985, 2021-7724,
2022-873, and 2022-4460. 05/08/2023
I'd like to request all responsive records produced in response to FOIA request #2017-2865, which was made on 3/30/2017. 05/08/2023
Please provide the following 1 inspection-related document in electronic PDF format: The 483 (in electronic format) for Human Drugs
inspection of PETNET SOLUTIONS, INC., 3728 PHILLIPS HWY STE 221, JACKSONVILLE, FLORIDA (FL) 32207, UNITED STATES (USA) -
Inspection, 2021-05-21 (3006896373). Please send documents as email attachments. 05/05/2023
Please provide the following 1 inspection-related document in electronic PDF format: The 483 (in electronic format) for Medical Device
inspection of G Surgical LLC., 9433 BEE CAVE RD BLDG 3 STE 101A, AUSTIN, TX, 78733-6135, UNITED STATES - Inspection, 2023-03-01
(3009169872). Please send documents as email attachments. 05/10/2023
inspection of Michael J Rosen MD., CLEVELAND CLINIC FOUND, 9500 EUCLID AVE # A-10, CLEVELAND, OH, 44195-0002, UNITED STATES -
inspection of Surgical Theater Inc., 23645 MERCANTILE RD STE M, BEACHWOOD, OH, 44122-5936, UNITED STATES - Inspection, 2023-03-
03 (3010197287). Please send documents as email attachments. 05/24/2023
inspection of Smiths Medical ASD Inc..,6000 NATHAN LN N, MINNEAPOLIS, MN, 55442-1690, UNITED STATES - Inspection, 2023-03-03
inspection of US Infusion, Inc.,6356 MANOR LN STE 101, SOUTH MIAMI, FL, 33143-4960, UNITED STATES - Inspection, 2023-03-06
inspection of EMIT Corporation.,1120 NASA PKWY STE 600, HOUSTON, TX, 77058-3365, UNITED STATES - Inspection, 2023-03-07
inspection of Micro Distributing I I, Ltd.,620 KENNEDY CT, BELTON, TX, 76513-4140, UNITED STATES - Inspection, 2023-03-07
inspection of Barrett Technology, LLC.,320 NEVADA ST, NEWTON, MA, 02460-1435, UNITED STATES - Inspection, 2023-03-07
inspection of WEG Surgical Solutions.,3703 ALLIANCE DR STE A, GREENSBORO, NC, 27407-2385, UNITED STATES - Inspection, 2023-03-08
All records relating to Oregon's Wild Harvest Inc.'s response to FDA's July 8, 2022 Warning Letter to the firm.
In an effort to ensure I have all the documentation on file, I would like to see all the interactions after the initial filing up to the final
approval for 510(k) K161461. This is for the BostonSight PD Prosthetic Device. I am (BostonSight is) the file holder of this 510(k).
Please send form 483 of IPCA labs piparia facility 05/16/2023
Please provide disclosable, redacted 483s, 483 Responses, and EIRs in electronic format (.pdf) that have been released since Thursday,
March 30, 2023. 05/30/2023
I am looking for any signed affidavits by Jackson Wilson Knoepfler. 05/02/2023
Our office would also like to supplement our initial request dated 4-18-2023 and respectfully request all reports of contamination,
injury, bacterial, sickness for Similac Neosure Formula Lot Number #48117RE347.
2022-5440, and 2022-5444. 05/08/2023
K103720, by FujiFilm.
We request the scans of 8 ANDA approval letters. There ANDAs were approved between 2008 and 2013. For example ANDA #78198 was
approved in 2008, 77589 in 2009, ANDA #203026 in 2013, ANDA #78169 in 2012, #200292 in 2011, #76237 in 2010, #78986 in 2011,
#201022 in 2012 05/30/2023
Randomized clinical trials where deep brain stimulation was used for Parkinson’s disease, essential tremor, dystonia, or epilepsy in
adult population and compared to medication, usual care, surgery, sham stimulation, placebo, or no intervention.
I am requesting these warning letters, untitled letters and notice-of-violation letter related to Avanida from 1980-2023.
All records related to Oregon's Wild Harvest Inc.'s response FDA's July 8, 2022, Warning Letter to the firm.
ADVERSE EVENTS COGENTIN, METFORMIN, PAXIL ETC 05/19/2023
Copy of the disclosable portions of the complete FDA response for the following File Numbers: 2022-5953, 2022-4406, 2019-9780, 2019-
9996, and 2020-4683. 05/16/2023
1. All documents and information produced in response to FDA FOIA Request No. 2022-3992; 2. All documents and information
produced in response to FDA FOIA Request No. 2021-535; 3. All documents and information produced in response to FDA FOIA
Request No. 2021-6401; 4. All documents and information produced in response to FDA FOIA Request No. 2018-8706; 5. All
documents and information produced in response to FDA FOIA Request No. 2019-7610; 6. All documents and information produced
in response to FDA FOIA Request No. 2021-5381; and 7. All documents and information produced in response to FDA FOIA Request
No. 2019-588. 05/16/2023
Please provide disclosable, redacted 483s, 483 Responses, and EIRs in electronic format (.pdf) that have been released since Thursday,
March 30, 2023. If the zipped files do not exceed 25 Megabytes, please send to support@fdazilla.com, otherwise please send these on
CD or DVD media to: Govzilla Inc., 1905 Marketview Drive, Suite 205 Yorkville, IL 60560 P 05/02/2023
Taiho Oncology Inc. is requesting individual case reports (MedWatch/CIOMS) for the following Case ID numbers to obtain additional
information. The case ID numbers were extracted from the FAERS database for Lonsurf (tipiracil/trifluridine) between the dates
01Jul2022 – 30Sep2022. Taiho Oncology Inc. is willing to pay the necessary fees associated with this request. 05/11/2023
2023-95, 2023-84, 2023-420, 2023-69, 2023-171 05/16/2023
2023-921, 2023-919, 2023-918, 2023-917, 2023-916 05/16/2023
2023-915, 2023-914, 2023-599, 2023-598, 2023-597 05/16/2023
2023-568, 2023-567, 2023-566, 2023-562, 2023-558 05/16/2023
2023-557, 2023-510, 2023-509, 2023-508, 2023-505 05/16/2023
2023-504, 2023-503, 2023-379, 2023-378, 2023-377 05/16/2023
2023-375, 2023-374, 2023-373, 2023-332, 2023-330 05/16/2023
2023-329, 2023-327, 2023-325, 2023-324, 2023-323 05/08/2023
2023-227, 2023-222, 2023-221, 2023-220, 2023-191 05/12/2023
2023-189, 2023-187, 2023-186, 2023-134, 2023-133 05/12/2023
2023-132, 2023-131, 2023-130, 2023-128, 2023-127 05/12/2023
2023-1027, 2023-1026, 2023-1024, 2023-2314, 2023-2313 05/12/2023
2023-2312, 2023-2273, 2023-2269, 2023-2226, 2023-2225 05/12/2023
2023-2224, 2023-2220, 2023-2219, 2023-2218, 2023-2217 05/12/2023
2023-2174, 2023-2173, 2023-2172, 2023-2171, 2023-2170 05/12/2023
2023-2169, 2023-2168, 2023-2167, 2023-2129, 2023-2126 05/12/2023
2023-682, 2023-231, 2023-1754, 2023-1450, 2023-1033 05/16/2023
2023-992, 2023-858, 2023-438, 2023-1875, 2023-1681 05/16/2023
2023-1718, 2023-687, 2023-1792, 2023-1183, 2023-446 05/16/2023
We hereby request the following documentation and appreciate your support on this: FDA Establishment Inspection Report for the FDA
inspection in 2023 on Rechon Life Sciences AB in Limhamm, Sweden.
Establishment Inspection Report for NAMSA (North American Science Associates) 6750 Wales Road, Northwood OH from 2011 and 2014 05/02/2023
Any complaints (whether by consumers, inspectors, regulatory bodies, or others) or unsatisfactory inspection reports regarding any
oxycodone product manufactured by Rhodes Pharmacy within the time frame of 1/1/2020 through 4/28/2023. Also looking for
information regarding all ingredients (active and inactive) and the quantities of those ingredients for oxycodone products manufactured
by Rhodes.
Report C and Report H referenced in Appendix 1 of the FDA CFSAN Administrative File Memorandum dated February 3, 2023 re
"Summary of consumer research reports on consumers' perceptions and understanding of plant-based milk alternatives." 05/31/2023
I am seeking non-confidential portions of the FDA Critical Path Innovation Meeting (CPIM) materials from February 2020, on the topic
"Master Protocol to Promote Expanded Access in Oncology". According to the FDA 2015 guidance, CPIM meetings include the original
request, preparation packages, and a written meeting summary originally sent to the CPIM meeting requester. 05/11/2023
I am seeking non-confidential portions of the FDA Critical Path Innovation Meeting (CPIM) materials from July 2021, on the topic "Use of
Artificial Intelligence (AI) to created Synthetic Controls in Clinical Trials". According to the FDA 2015 guidance, CPIM meetings include
the original request, preparation packages, and a written meeting summary originally sent to the CPIM meeting requester. 05/11/2023
I am seeking non-confidential portions of the FDA Critical Path Innovation Meeting (CPIM) materials from June 2022, on the topic "Use
of Digital Pathology in Good Laboratory Practice (GLP) Environment for Nonclinical Studies". According to the FDA 2015 guidance, CPIM
meetings include the original request, preparation packages, and a written meeting summary originally sent to the CPIM meeting
requester. 05/11/2023
I am seeking non-confidential portions of the FDA Critical Path Innovation Meeting (CPIM) materials from January 2017, on the topic "A
Tool to Assess Clinical Trial Site Performance and Data Quality". According to the FDA 2015 guidance, CPIM meetings include the
original request, preparation packages, and a written meeting summary originally sent to the CPIM meeting requester. 05/11/2023
I am seeking non-confidential portions of the FDA Critical Path Innovation Meeting (CPIM) materials from July 2021, on the topic
"Obtaining Reliability and Acceptance of Novel Endpoints using Digital Health Technologies". According to the FDA 2015 guidance,
CPIM meetings include the original request, preparation packages, and a written meeting summary originally sent to the CPIM meeting
requester. 05/11/2023
I am requesting email records between Kyle Orwig from the email address orwigke@upmc.edu and the Federal and Drug
Administration that include the words "Spermatogonial" and "clinical trial" from 2021 current.
05/25/2023
Please provide all documents and other materials on the addition of new warnings to the FDA's FOIA website 05/05/2023
Documents and records pertaining to and which relate to Florida’s and other state’s Section 804 Importation Program (“SIP”).
INDIVIDUAL RECS 05/25/2023
Copy of the current Office of Criminal Investigations Policy titled “Badges and Credentials” and a copy of the immediately preceding
policy and/or policies the current version replaced and/or made obsolete ETC 05/30/2023
The "Consent Decree Correspondence/Non-Compliance Letter" issued to Sun Pharma's Mohali facility in April 2023 05/19/2023
I hereby request the following records: Firm compliance inspections (i.e., inspection database), including “pre-approval inspections
(PAI),” and their corresponding citations data (i.e., citations database) in the pharmaceutical and medical device industries, from
10/1/1999 to the present. Please see the attached request letter for details. Thanks. 05/04/2023
records related to 4-2 vote by FDA's OTC Plaque Subcommittee Dec. 7 1995 which recommended that in classifying OTC plaque
products, "all references to the control of dental plaque, or its equivalents, with or without qualification, will be interpreted as a drug
claim."
We respectfully request all entry-line records that contain any of the following data points in reference to any entry’s FSVP Importer,
Importer of Record, or Consignee; for entry-lines with submission or arrival dates from April 1 to April 30, 2023: 1) DUNS Number /
Unique Facility Identifier (UFI) of 080801169 2) Name of United Safety Agents, United Safety, or variations of the same ETC 05/18/2023
Documents setting out the FDA's projected costs per year for the interagency task force that would be set up under the Interagency
Patent Coordination and Improvement Act (S.4430 and S.79). The costs were communicated to the offices of Senators Dick Durbin and
Thom Tillis by the FDA office of legislation. Please provide these documents to me by end of day, May 14, at the very latest.
CV Charles M Edwards, Cassandra L Winters, Michelle E Noonan-Smith, ETC 05/15/2023
The following two (2) CSV files: 1) Listing of all INSPECTIONS since Sunday, May 1, 2022 (in CSV format) with the following fields:
FEI Number, Inspection Start Date, Inspection End Date, Legal Name, Address, City Name, State Code, Zip Code, Country Name, FDA483,
Full Name, District, Center, INSPECTION REASON 2) Listing of releasable inspection CITATIONS (from FDA's FACTS database) for each
company since Sunday, May 1, 2022 in CSV format with the following columns: INSPECTION_ID, YEAR, INSPECTION_START_DATE,
INSPECTION_END_DATE, FEI_NUMBER, FIRM_Name, REF_NO, SHORT_DESC, Inspection Classification, Inspection Project Area. Please
send CSV file to support@fdazilla.com 05/31/2023
Redacted Establishment Inspection for: Wexler Surgical, Inc. 11333 Chimney Rock Road, Ste 110 Houston, Texas 77035
Requesting a copy of the currently approved package insert labeling for Fentanyl Citrate Injection, under NDA 019101. 05/19/2023
I am an investment professional at an asset management firm and would like to request FOIA control # 2023-2859. 05/12/2023
Action Package for Approval for NDA 215430 - Auvelity. A request was sent to the Division of Drug Information enquiring about why
the review was not published, as per FDAAA. The response suggested filling out this FOIA. 05/11/2023
On the publicly available FDA site: https://www.fda.gov/media/119312/download, FDA provides a list of companies participating in the
FDA Foreign Supplier Verification Programs. We request a spreadsheet which includes the 23 publicly available data points for all entries
that led to Pamex Foods Inc.'s inclusion in this list for the last 2 years (March 1, 2021 - March 31, 2023). See attached Waiver. 05/10/2023
I request all DMEPA reviews related to wrong frequency errors related to methotrexate used once daily instead of once weekly for
rheumatoid arthritis, psoriasis or Crohn’s disease and steps taken by FDA to mitigate the risk of errors.
Hello, Please provide all documents and other materials regarding the FDA-Reagan Udall Foundation project described by Dr. Califf in
the link below, including preliminary plans for the project, proposed and actual funding, and all FDA employees proposed and assigned
to the project https://www.fda.gov/news-events/fda-voices/highlighting-major-issues-critical-fda-across-our-diverse-agency-after-one-
year-back
All available Summary Basis for Approval documents for NDA 018669, generic name niclosamide (NICLOCIDE) that was marketed by the
Sponsor Bayer but withdrawn by the Sponsor. 05/19/2023
that led to Mexico Distributor, Inc's inclusion in this list for the last 2 years (March 1, 2021 - March 31, 2023). See attached Waiver. 05/10/2023
that led to Morton Salt Inc.'s inclusion in this list for the last 2 years (March 1, 2021 - March 31, 2023). See attached Waiver. 05/18/2023
that led to XF Enterprises, Inc.'s inclusion in this list for the last 2 years (March 1, 2021 - March 31, 2023). See attached Waiver. 05/10/2023
that led to Accardi Foods' inclusion in this list for the last 2 years (March 1, 2021 - March 31, 2023). See attached Waiver. 05/10/2023
that led to Edward & Sons Trading Co., Inc.'s inclusion in this list for the last 2 years (March 1, 2021 - March 31, 2023). See attached
Waiver. 05/18/2023
that led to Select Produce LLC's inclusion in this list for the last 2 years (March 1, 2021 - March 31, 2023). See attached Waiver. 05/10/2023
that led to Loumidis Foods, Inc.'s inclusion in this list for the last 2 years (March 1, 2021 - March 31, 2023). See attached Waiver. 05/10/2023
that led to Ikal LLC's inclusion in this list for the last 2 years (March 1, 2021 - March 31, 2023). See attached Waiver. 05/18/2023
that led to Big V Feeds' inclusion in this list for the last 2 years (March 1, 2021 - March 31, 2023). See attached Waiver. 05/10/2023
ANDA application ANDA214010, for lyophilized amphotericin B from TTY Biopharm Company 05/30/2023
Establishment Inspection Report for Bioresearch Monitoring Inspection of Eli Lilly and Company, FEI 1819470 conducted September 26-
30, 2022. The inspection ID is 1181732. 05/30/2023
Establishment Inspection Report for Eli Lilly FEI 1819470, inspection ID 1137226 conducted 02/18/2021 to 03/16/2021. As the
inspected firm, Lilly requests the fully unredacted report. 05/22/2023
Seeking the records for: Reference listed drug: CORTROSYN - cosyntropin injection, powder, lyophilized, for solution, 0.25mg NDC:
0548-5900-00 MAH: Amphastar Pharmaceuticals, Inc. (ID/FEI: 024736733) Record requested: Module 3, section 3.2.P (drug product) of
CTD, NDA016750, start date 08/01/2003 05/25/2023
483 issued to KOFU FACTORY OF TERUMO CORP. in Japan (FEI Number 3003752255) on FDA inspection. 05/31/2023
FORM 483 for IPCA Labs Piparia (Silvassa) Inspection from April 18th to 26th April 2023 USFDA Issued 3 observations in the Form 483 05/16/2023
2023-1624, 2023-1705, 2023-2804, 2023-2854, 2023-3246 05/12/2023
2023-2543, 2023-2936, 2023-2815, 2023-2816, 2023-3062, 2023-3063 05/12/2023
2023-2629 05/09/2023
The warning letter sent by the FDA to Invasix (FEI Number 3007350642) in November of 2012. The case/injunction ID is 352599. 05/02/2023
All emails sent to or from the email accounts of DCD Director Rochelle Walensky and her Chief of Staff Sherri Berger between March 21,
2022 and March 31, 2022 that contain the word “booster.”
FDA-1988-P-0001 FDA-1988-P-0006 FDA-1988-P-0007 FDA-1988-P-0008 FDA-1988-P-0012 FDA-1988-P-0013 FDA-1988-P-0020 FDA-
1988-P-0022 FDA-1988-P-0023 FDA-1988-P-0024 etc
FDA-1987-P-0002 FDA-1987-P-0003 FDA-1987-P-0005 FDA-1987-P-0015 FDA-1987-P-0016 etc
FAERS Case ID #21208649 Product Symjepi (epinephrine injection) Received by FDA 08/11/2022 confusion product labeling use 05/19/2023
I am an investment professional and this is a request under the Freedom of Information Act. I would like to request any adverse events
reported for Syfovre (branded name / marketed by Apellis Pharmaceutical) or pegcetacoplan (generic name) between February 17,
2023 and April 28, 2023 05/08/2023
A copy of any state referral letter sent from the Office of Regulatory Affairs to the Texas State Board of Pharmacy for inspections of
Revive Rx LLC d/b/a Revive Rx Pharmacy (FEI 3016710945) that concluded on August 6, 2021 and May 4, 2022. 05/09/2023
Hello, I would like to request any Form 483’s issued to Piramal Health Solutions (FEI 3006419237) located in Lexington, KY after January
30, 2023. Thank you. 05/03/2023
All records and response letters provided for 2021-2498 05/23/2023
Hikma herewith requests Summary Basis of Approval Package for MINOCIN (Minocycline HCl) INJECTION, 100 mg base/ vial (NDA#
050444) registered under Rempex Pharmaceuticals Inc (a wholly owned subsidiary of Melinta Therapeutics LLC). Hikma is specifically
looking for Administrative Documents and Correspondence, Summary Review, Chemistry Review and Biopharmaceutics Review in the
Summary Basis of Approval Package. 05/19/2023
Copy of FOI request files 2023-1843 and 2023-1068. 05/24/2023
I'm writing to request the IND (investigational new drug) filing for Entresto, Novartis' drug for chronic heart failure with LVEF below
normal. I understand that parts of an IND filing may be proprietary and confidential. I am specifically interested in obtaining the
preclinical studies that were run as part of this filing. 05/04/2023
Case IDs: 19513363 19756591 19864981 20332374 20529062 15399268 15299511 15272838 15201712 15169360 14878617
14770310 05/19/2023
Drug approval Summary Review documents for NDA 217171 Syfovre (pegcetacoplan) and NDA 216403 Filspari (sparsentan)
FGI requests any contracts for consultants or outside experts related to the development of any rulemaking or other agency action on
low nicotine products. This should include any contractual work, grants, or any other federal awards made for the purpose of assisting in
any potential agency on low nicotine.
1. Any and all records of communications a. Between any FDA personnel and any person or entity (including but not limited to any
organization, association, corporation, Federal employees, and or non-Federal employees) mentioning “mifepristone” (which includes,
but is not limited to, such terms as Mifeprex, Mifegyne, Korlym, abortion pill, RU-486, RU-38486, ZK-98296, and/or the mifepristone
chemical description of “11ß-(4-(dimethylamino)phenyl)-17a-(1-propynyl)estra-4,9-dien-17ß-ol-3-one”or other names used by the same
compound in its generic form) for use as an abortifacient,
• Mahadevappa Hunasikatti MD FCCP and Nargues Weir MD FCCP FAASM ATSF, Consult request on Lumryz (Apr. 29, 2023); and •
Division of Neurology 1, Office of Orphan Products Development Consult Request #16-5302 (May 1, 2023). 05/13/2023
Information related to regulatory feedback/guidance provided to companies or investigators looking to initiate in-human clinical studies
using ibogaine, noribogaine, or 18-methoxycoronaridine in the United States. 05/31/2023
All communications, including emails, text messages, memos, and notes from phone calls, exchanged between the office of former FDA
commissioner Scott Gottlieb and the office of the White House, including White House associate counsel and assistant to the President
Steven Menashi, containing the words “Juul” or “Altria” or “vaping”. Please limit your search to within the following dates: December
20, 2018, and March 1, 2019.
I am an investment professional at an asset management firm and would like to request the summary EIR issued in 2023 for the
following facility: Rentschler Biopharma SE Erwin-Rentschler-Strasse 21 Laupheim, Baden-Wuertemburg-Germany 88471 FEI #:
1000291122 If there is no summary EIR found, please confirm whether it is in progress. If possible delivery in electronic format is
requested. 05/17/2023
Copy of the disclosable portions of the 510(k) for K191332.
K093243
Hello, I am looking for all records of adverse events related to Benadryl (diphenhydramine), including deaths and injuries related to the
TikTok Challenge. Ideally, the data would include the overall number of adverse events per year, the age of the person, the date the
injury or death occurred and whether the person died or survived the incident. 05/19/2023
Request for any and all records responsive to FOIA requests with control numbers 2020-5070, and 2020-5069, submitted by Bloomberg
News. 05/24/2023
I am seeking all information related to my Grandfathered Tobacco Product brand Custom Blends. Please see attached file with letter.
Thank You
510k summary of K151837 and the 510k summary of the predicate device used in K151837
Hello, I would like to request any Form 483’s issued to Piramal Health Solutions (FEI 3006419237) located in Lexington, KY after January
30, 2023. Thank you. 05/03/2023
A Study of LY3298176 in Healthy Participants and Participants With Type 2 Diabetes (T2DM) (NCT02759107) study protocol LY3298176
Investigator's Brochure
I request copies of any email communications sent by or received by John Marler, MD, that contain any of the following terms: fisher
wallace, fischer wallace, ces, ces device, ces devices, cranial electrotherapy, cranial electrotherapy stimulation, cranial electrotherapy
stimulator, chip fisher, kelly roman, circadia
1. All statements, notes, tests, reports, studies, abstracts, data or other information concerning any Dollar General distribution center
and/or warehouse inspection(s) and/or investigations. 2. All correspondence and communications to or from the FDA, to any other
entity, concerning any Dollar General distribution center and/or warehouse inspection(s) and/or investigations. ETC
STAFF DIRECTORY 05/04/2023
All Freedom of Information Act requests filed with the U.S. Food and Drug Administration by the
“American Kratom Association,” “Mac Haddow” or “C. McClain Haddow” from 01/01/2014 to the date
that this request is processed 05/11/2023
I am requesting the redacted 510(k) full submission for K192162 NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole
Cover, DC Plate. The NeuroVention 510(k) submission was cleared on March 13, 2020. I would like to review the testing that was
provided. Please provide preferably in electronic format in PDF to the email above.
Form FDA 483 for NerPharmMa S.r.l (FEI#: 3004762406; Inspected site Address: Viale Luigi Pasteur, 10, 20014 Verviano, Milan Italy)
from most recent FDA inspection conducted February 6th - 20th, 2023.
v We are writing to request via FOIA, the FDA Reviews for New Drug Application #217171.
FOIA LOGS 05/09/2023
K202100, Neocis Guidance System
K163232 05/08/2023
Copy of the disclosable portions of the EIR for the 12/27/2021 - 01/07/2022 inspection of Kenia Castro,. located in Hialeah, FL. This
inspection pertains to human drugs.
K192415 and K200948
Copy of the disclosable portions of the EIR for the 12/13/2021 - 2/29/2021 inspection of Amarex Clinical Research, located at Amarex
Clinical Research, Germantown, MD. This inspection pertains to human drugs. 05/10/2023
Copy of the disclosable portions of the NGE and RAR for the inspection of Ethicon Endo-Surgery SA de CV, Planta II, Juarez, Mexico, end
date 04-21-2017. FEI# 3003565435. This inspection pertains to medical devices.
Copy of the disclosable portions of the NGE and RAR for the inspection of Hollister Incorporated, Oud Gastel, Netherlands, end date 07-
06-2018. FEI# 3014404707. This inspection pertains to medical devices.
This request is for the complete 510(k) file, including all submissions, communications to and from the U.S. Food and Drug
Administration, and any reviewer’s notes, for the following: K220540 for the ProGrip™ Self-Gripping Polypropylene Mesh submitted by
Covidien.
Administration, and any reviewer’s notes, for the following: K120897 for the ProGrip™ Laparoscopic Self-Fixating Mesh submitted by
Sofradim Production.
Administration, and any reviewer’s notes, for the following: K140941 for the ProGrip™ Self-Gripping Polypropylene Mesh, Parietene Flat
Sheet Mesh submitted by Sofradim Production.
Administration, and any reviewer’s notes, for the following: K143386 for the ProGrip™ Laparoscopic Self-Fixating Mesh submitted by
Sofradim Production.
2023-3058 05/09/2023
2849, and 2022-2883. 05/24/2023
2023-1353 05/09/2023
2022-3520, 2023-650, 2023-664, 2023-1986,2023-2358 05/24/2023
Please provide the 510(k) Summary and 510(k) device description, including any disclosable portions of physical or technical
descriptions, for 510(k) Number K220677 (Device Name: Kurin Blood Culture Collection Set with Kurin Lock Technology).
5148, and 2022-5344. 05/24/2023
I'm am looking for the FILSPARI (sparsentan) FDA review documents. FILSPARI was approved by FDA in Feb 2022. The documents are not
available on the accessdata.fda.gov site. I am interested in both the review and the summary review. FILSPARI was assigned NDA#
216403. 05/04/2023
2023-2359, 2023-2360,2023-2646, 2023-2648, 2023-2654 05/24/2023
5934, and 2022-5937. 05/24/2023
that led to Mama Mata's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver. 05/18/2023
We kindly request all documents pertaining to the safe and Generally Recognized as Safe (GRAS) use of fluid whole milk as an ingredient
in infant formula. 05/31/2023
We kindly request all documents pertaining to the Food Additive Petition (FAP) submitted by Cargill, Inc. [Docket No. FDA–2022–F–
2725], proposing that the food additive regulations be amended to provide for the safe use of hydrogen peroxide (CAS Reg. No. 7722–
84–1) as an antimicrobial agent, oxidizing and reducing agent, bleaching agent, and to remove sulfur dioxide.
that led to Ale & Wang's inclusion in previously published date ranges of this list for the last 2 years (April 1, 2021 - April 30, 2023). See
attached Waiver. 05/18/2023
that led to the inclusion of Aquatic Sales Solutions LLC (dba Bulk Reef Supply) in previously published date ranges of this list for the last 2
years (April 1, 2021 - April 30, 2023). See attached Waiver.
Establishment Inspection Report for Dr. Tory Sullivan, 16100 NE 16th Ave., Suite A, North Miami Beach, FL 33162 05/09/2023
that led to Treto's & Sons Inc.'s inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver. 05/18/2023
that led to My Favorite Company, Inc.'s inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver. 05/24/2023
that led to Wholesale Unlimited, Inc.'s inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver. 05/18/2023
We request the dates of any Establishment Inspection Reports or Form 483s issued from Sep. 30, 2022 to May 1, 2023 for inspections
occurring at the below addresses. Please note that we are not requesting the form 483s or EIRs. We are only seeking an
acknowledgement of whether EIRs or Form 483s exist and what dates on which they were issued. Ajinomoto, Main Campus - 11040
Roselle Street, San Diego, CA 92121 etc 05/19/2023
The Associated Press requests copies of and access to any written, electronic, email or other notifications to FDA by Abbott Laboratories
regarding any powdered infant formula products contaminated with Cronobacter, Salmonella or any other pathogen from May 1, 2022
to May 3, 2023, including any notifications required by the May 16, 2022 consent decree filed in the Western District of Michigan.
1) All emails to/from the email address douglas.balentine@fda.hhs.gov ¿ From the following email domains: @nam.org @idfa.org
@usdec.org @infantnutrition.org and @corn.org ¿ With any of the words: "infant formula" "follow-up formula" "follow-on
formula" "breast milk substitute" "breast-milk substitute" "breastmilk substitute" "milk formula" "formulated milks" "growing up milks"
"foods for infants" etc
Acme Smoked Fish requests a spreadsheet of the following 23 data fields for imports of any FDA regulated product entering the United
States that listed this firm as the importer during the period of April 1, 2021 – April 30, 2023. Acme Smoked Fish waives confidentiality
between FDA and Registrar Corp for the purposes of this request (see attached waiver). etc 05/18/2023
A copy of the 42-page letter dated May 1, 2023 titled "Determination that Xywav'’s (NDA 212690) unexpired orphan-drug exclusivity
(“ODE”) does not block approval of Lumryz (NDA 214755)" signed by Sandra S. Retzky, D.O., J.D., M.P.H., Director, Office of Orphan
Products Development, FDA. 05/13/2023
Please send a list of closed FOIA requests to the FDA (please include requester, organization, FOIA reference #, subject matter) that
received exemptions during April, and the exemption that was applied. Please send this in CSV or xlsx format if possible. 05/05/2023
FAERS case report # 22134131, for the drug Syfovre/pegcetacoplan 05/19/2023
Any materials regarding TransCon PTH (palopegteriparatide) AERS, or in the alternative, the response to FDA FOIA request 2023-2791. 05/19/2023
Any form 483s for the "Krystal Biotech" facility "Ancoris," likely at 2100 Wharton St., Pittsburgh, PA (the product is a human drug), or in
the alternative, any response to FDA FOIA request 2023-2792.
All FAERS reports on Vyvgart (generic name efgartigimod alfa-fcab). 05/19/2023
All FDA FAERS reports on pegcetacoplan (Syfovre). 05/19/2023
I am requesting a copy of the disclosable portions of the orphan drug exclusivity memorandum(a) (or equivalent decisional documents if
no exclusivity memoranda exist) for Lumryz (sodium oxybate extended-release oral suspension, by Avadel Pharmaceuticals, NDA
214755) approved May 1, 2023 for the treatment of cataplexy or EDS in adults with narcolepsy and orphan designated for the treatment
of narcolepsy.
I am requesting a copy of the disclosable portions of the approval package for Lumryz (sodium oxybate extended-release oral
suspension, by Avadel Pharmaceuticals, NDA 214755) approved May 1, 2023 for the treatment of cataplexy or EDS in adults with
narcolepsy and orphan designated for the treatment of narcolepsy. 05/17/2023
The full case file documents for these report numbers: 3010511300-2023-00045 3010511300-2023-00126 MW5093653 MW5092695
MW5092685 MW5092656 MW5112152 MW5102788 MW5092654, or in the alternative, all responses to FDA FOIA request 2023-2801. 05/19/2023
I am requesting a copy of the disclosable portions of the Orphan Drug Designation request(s), reviews, exclusivity documents, and
related internal and external correspondence for Lumryz, (sodium oxybate extended-release oral suspension, by Avadel
Pharmaceuticals, NDA 214755) approved May 1, 2023 for the treatment of cataplexy or EDS in adults with narcolepsy and orphan
designated for the treatment of narcolepsy. 05/31/2023
We request the Establishment Inspection Reports or Form 483s issued from Sep. 30, 2022 to May 1, 2023 for inspections occurring at
the below addresses. Ajinomoto Bio-Pharma, Main Campus - 11040 Roselle Street, San Diego, CA 92121 Ajinomoto Bio-Pharma,
Warehouse - 9393 Waples Street , Suite 110, San Diego, CA 92121 Ajinomoto Bio-Pharma, Highly Potent/ADC Facility etc 05/19/2023
FDA review memoranda related to the No Objection Letter (NOL) provided to Fraser Plastics (Fraser), NOL #261, on January 27, 2022
Copy of Boston Scientific’s Emblem S-ICD SMART Pass software update FDA PMA or supplement including any communications related
to the same etc
We request copies of the following: 1) complete “Breakthrough Therapy Designation Application” for Zimura (avacincaptad pegol) for
geographic atrophy, including the completed CDER Breakthrough Therapy Designation Determination Review Template (BTDDRT); and
2) the Breakthrough Therapy Designation determination review presentation for Zimura (avacincaptad pegol) for geographic atrophy. 05/04/2023
We request the FDA Adverse Event Reporting System (FAERS) reports on Zimura (avacincaptad pegol). Please search for both drug
names. 05/19/2023
We request the Drug Approval Package documents for NDA 217171 (Syfovre [pegcetacoplan]), including documents corresponding to:
Administrative and Correspondence Documents, Statistical Review, Nonclinical Review, Clinical Review, and Clinical Pharmacology and
Biopharmaceutics Review. Please search for both drug names. 05/04/2023
We request the Review Summary Basis of Approval documents for NDA 217171 (Syfovre [pegcetacoplan injection]), which was approved
on February 17, 2023. Please search for both drug names. 05/04/2023
We request copies of the following: 1) complete “Breakthrough Therapy Designation Application” for Syfovre (pegcetacoplan) for
geographic atrophy, including the completed CDER Breakthrough Therapy Designation Determination Review Template (BTDDRT); and
2) the Breakthrough Therapy Designation determination review presentation for Syfovre (pegcetacoplan) for geographic atrophy.
We request the FDA Adverse Event Reporting System (FAERS) reports on Syfovre (pegcetacoplan injection) (NDA 217171). Please search
for both drug names. 05/19/2023
483 issued to Fuji Yakuhin Co., Ltd., in Japan (FEI Number 3008538640) on FDA CDER inspection :20221125) 05/31/2023
We,TIANJIN OKAY INTERNATIONAL TRADING CO.,LTD,ship out 2 fcls xanthan gum to SFC GLOBAL SUPPLY CHAIN, INC.115 W COLLEGE DR
, MARSHALL, MINNESOTA, 56258,USA.FDA FOIA CNEE IS SFC GLOBAL SUPPLY CHAIN, INC.29 Mason Dr New Britain, CT 06052-1929 US,
Pls. Check WHY THEY CAN PASS FDA TESTING WITH DIFFERENT ADDRESS AND DUNS ? PLS GIVE US WITH FDA FOIA LETTER STATE THE
rationality explaination. Entry/DOC/Line W96-3600205-2/12/1 05/09/2023
Facility: GC Pharma (in South Korea) Request record: Form 483 FDA Inspection period: 2023/Apr/17 to 2023/Apr/28 Type of inspection:
PLI
RECS RE METFORMING RECALL, AMNEAL
WE ARE SHIPPER OF THIS BILL ,THE CNEE IS SFC GLOBAL SUPPLY CHAIN, INC.115 W COLLEGE DR , MARSHALL, MINNESOTA, 56258,USA.
FDA FOIA CNEE IS SFC GLOBAL SUPPLY CHAIN, INC.29 Mason Dr New Britain, CT 06052-1929 US,
HOW CAN PASS FDA THEN PASS CUSTOMS WITH DIFFERENT ADDRESS AND DUNS NO.,
FDA, PLS GIVE A EXPLAINATION IN OFFICE LETTER. 05/09/2023
inspection of PPD Development, L.P..,8551 RESEARCH WAY, SUITE 90, MIDDLETON, WISCONSIN (WI) 53562, UNITED STATES (USA) -
inspection of Nelson Laboratories Fairfield Inc.,122 FAIRFIELD RD., FAIRFIELD, NEW JERSEY (NJ) 07004, UNITED STATES (USA) -
inspection of Conformis, Inc..,600 TECHNOLOGY PARK DR # 400, BILLERICA, MA, 01821-4154, UNITED STATES - Inspection, 2023-03-09
Please see attached letter. • Any discipline reviews (including clinical and statistical reviews), multidisciplinary reviews, integrated
reviews, and/or summary reviews prepared by FDA in its evaluation of Cephalon’s jet-lag sNDA.
Hi, I would like any and all records pertaining to research, data, and/or studies supporting the efficacy and/or safety of CAROL COMPANY
NUFACE micro-current devices as well as any adverse reports reported, whether followed up on by the FDA or not. Thank you. 05/23/2023
inspection of Medtronic MiniMed, Inc, 18000 DEVONSHIRE ST, NORTHRIDGE, CA, 91325-1219, UNITED STATES - Inspection, 2023-03-10
inspection of Advanced Instrumentations, Inc., 6800 NW 77TH CT, MIAMI, FL, 33166-2713, UNITED STATES - Inspection, 2023-03-10
inspection of DentiMax , Inc., 4115 E VALLEY AUTO DR STE 101, MESA, AZ, 85206-4610, UNITED STATES - Inspection, 2023-03-10
inspection of NEXALIN TECHNOLOGY INC., 1776 YORKTOWN ST STE 550, HOUSTON, TX, 77056-4180, UNITED STATES - Inspection, 2023-
03-10 (3014498660). Please send documents as email attachments. 05/10/2023
inspection of MEDIA PLUS, LLC., 270 ARTHUR AVE, ENGLEWOOD CLIFFS, NJ, 07632-2609, UNITED STATES - Inspection, 2023-03-10
inspection of Cambridge Diagnostic Products, Inc., 6880 NW 17TH AVE, FT LAUDERDALE, FL, 33309-1524, UNITED STATES - Inspection,
2023-03-16 (1029182). Please send documents as email attachments.
inspection of Orthofix U.S. LLC., 3451 PLANO PKWY, LEWISVILLE, TX, 75056-9453, UNITED STATES - Inspection, 2023-03-17 (2183449).
Please send documents as email attachments. 05/16/2023
1) I'm requesting copies of the recall strategy documents that medical devices manufacturers (recalling firms) have sent to the FDA
between 25 November 2018 and today (1 May 2023). I'm only requesting the recall strategies that concern medical devices. These recall
strategies should contain information detailing the depth of recall that the medical devices manufacturers were planning to undertake
as part of each recall strategy. etc 05/12/2023
Please provide our office with the full Maude Event Report # MW5098195. Please see the attached HIPAA auth signed by our client.
correspondence between the FDA and Reata Pharmaceuticals, Inc., including any person or entity acting on its behalf, between October
1, 2016 - December 31, 2016, September 1, 2018 - October 15, 2018, February 1, 2019 - March 15, 2019, January 1, 2020 – February 15,
2020, September 1, 2020 – October 15, 2020, and October 1, 2021 - December 6, 2021
1. Copies of all FDA Form 483s, EIRs and inspection records related to Boston Scientific Corporation's manufacturing facility located at
4100 Hamline Ave N, Saint Paul, MN 55112-5700. 2. Copy of Boston Scientific’s Emblem S-ICD SMART Pass software update FDA PMA or
supplement including any communications related to the same etc
Please provide the Form 483 associated with the FDA’s inspection of Azurity Pharmaceuticals, Inc.'s (FEI #: 3003395329) Wilmington, MA
facility that concluded on 3/2/2023. Facility address: 841 Woburn St, Wilmington, MA 01887-3414. 05/11/2023
We would like to request the following FAERS case reports on behalf of our client Pacira: 22160899, 22115832,22083666. 05/19/2023
We would like to request the following FAERS case reports on behalf of our client Harrow: 22136579 21878038, 22101838, 22101675,
22098047, 21449574. 05/19/2023
Anklam Extrakt GmbH 1) Dates of any facility inspections from 04 May 2018 and forward; 2) Any and all noted observations,
objections, and comments during such facility inspections such as a Form-483 or otherwise, as well as any responses thereto; 3) A list
of all ingredients and/or products packed, handled or stored by Quality Candy that have been subject to, implicated in, or impetus for a
recall from 04 May 2018 to present; etc
I am submitting a FOIA request to the FDA regarding NDA 214755 (Lumryz - sodium oxybate) to receive copies of the disclosable
portions of the following documents: DN1, Office of Orphan Products Development Consult Request #16-5302 (May 1, 2023) 05/16/2023
portions of the following documents: Avadel, Exclusivity Claim—Supplemental Information in Demonstration of Clinical Superiority of
FT218 (Jul. 14, 2021) submitted to the file for NDA 214755 I ask that the information be provided electronically by email if possible. 05/31/2023
portions of the following documents: Avadel Exclusivity Claim (Dec. 15, 2020) submitted to the file for NDA 214755 I ask that the
information be provided electronically by email if possible. I approve fees up to $50 before being notified. 05/31/2023
portions of the following documents: Letter from Clete A. Kushida to Sandra Retzky, OOPD regarding superiority of Lumryz (Jan. 3,
2023) I ask that the information be provided electronically by email if possible. I approve fees up to $50 before being notified.
portions of the following documents: Mahadevappa Hunasikatti MD FCCP and Nargues Weir MD FCCP FAASM ATSF, Consult request on
Lumryz (Apr. 29, 2023) 05/15/2023
Case #9619731, which documents an extravasation injury from esmolol, digoxin and involves betamethasone 05/19/2023
FDA FAERS database entries for BRIUMVI (generic name ublituximab-xiiy). 05/19/2023
I am an investment professional at an asset management firm and would like to request the Form 483(s) for the inspection occurring on
03/31/2023 for SpringWorks Therapeutics, Inc. located at 5310 S Alston Ave Ste 230, Durham NC 27713-4381. The FEI number is
3026006210. 05/23/2023
I am an investment professional at an asset management firm and would like to request any Form 483(s) issued for inspections
occurring from 03/31/2023 – present for WuXi Biologics Co., Ltd. located at 108 Meiliang Road, Mashan, Binhu District, Wuxi, Jiangsu
214092, China. The FEIN is 3010606982. If there are no 483s, please confirm whether or not the facility has been inspected in 2023. 05/31/2023
I am an investment professional at an asset management firm and would like to request any Form 483(s) issued for inspections
occurring from 03/31/2023 – present for Suzhou Union Biopharm Biosciences Co., Ltd. located at No. 999 Longqiao Road, Wujiang
District, Jiangsu Province, China. If there are no 483s, please confirm whether or not the facility has been inspected in 2023.
communication (letter, email) from Pfizer to FDA for the discontinuation of the subjects enrolled in the Vaccine Against Lyme for
Outdoor Recreationists (VALOR) (NCT05477524) Phase 3 clinical study. 05/24/2023
ISPEX Fredrich-Wencker-Strasse 11, D-97215 UFFENHEIM Manufacturing site Address: AM Brünnlein 14 Gewerbegebiet Nord D-9725
UFFENHEIM Germany and/or any associated manufacturing locations or offices. has a webpage located at: neu.echinacea-ispex.de 1)
Dates of any facility inspections from 04 May 2018 and forward; 2) Any and all noted observations, objections, and comments during
such facility inspections such as a Form-483 or otherwise, as well as any responses thereto; ETC
Orphan drug application review grant package for Sparsentan (Filspari).

Generic Name - sparsentan
Trade Name - Filspari
Date Designated - 01/11/2021.
Orphan Designation - Treatment of immunoglobulin A (IgA) nephropathy.
Orphan Designation Status -Designated/Approved.
Sponsor - Travere Therapeutics, Inc., 3611 Valley Centre Drive, Suite 300, San Diego, California 92130, United States.
Seeking EIR from regulatory inspection of our company that occurred 4/5/2022 - 4/13/2022. FEI Number 3003291321.
FOIA Control Number 2019-5092 – We are requesting a copy of files that were previously released by FDA under FOIA Control Number
2019-5092: Premarket Notification K183311 (Invenix Infusion System (IIS)) 05/09/2023
Copy of the disclosable portions of the NGE and RAR for the inspection of AROA Biosurgery, LTD., Lower Hutt, New Zealand, end date
09-15-2017. FEI# 3007321028. This inspection pertains to medical devices.
Copy of the disclosable portions of the NGE and RAR for the inspection of NordicNeuroLab AS, BERGEN, Norway, end date 11-09-2018.
FEI# 3006738448. This inspection pertains to medical devices.
Copy of the disclosable portions of the NGE and RAR for the inspection of Gentian AS, Moss, Norway, end date 03-08-2018. FEI#
3006801241. This inspection pertains to medical devices.
Copy of the disclosable portions of the NGE and RAR for the inspection of MP Biomedicals Asia Pacific Ptd Ltd, Singapore, Singapore,
end date 07-13-2017. FEI# 3008819649. This inspection pertains to medical devices.
I am an investment professional and this is a request under the Freedom of Information Act. I would like to request the detailed adverse
event report in Excel and PDF for Syfovre (pegcetacoplan injection) case # 22134131 and 22217478. 05/19/2023
Copy of the disclosable portions of the NGE and RAR for the inspection of Indiba Sa, Barcelona, Spain, end date 12-13-2018. FEI#
2023-2039, 2023-2042, 2023-2043, 2023-2044, 2023-2045 05/24/2023
Details of Form 483 issued to IPCA's Piparia (Silvassa) unit (FEI number 3005977675) inspected between April 18 to 26, 2023 05/16/2023
Syforve MEETING MATERIALS 05/18/2023
CORRESPONDENCE WITH TUS 05/11/2023
WE ARE SHIPPER FOR Entry/DOC/Line W96-3600205-2/12/1
Pls provide the info above importer name and address and DUNS. 05/09/2023
On Dec 15, 2020 the FDA held an advisory committee to discuss the approval of Entresto in HFpEF. A few months ago, I was able to
access the adcom briefing documents on the link below. Today, I can no longer access them. These should be publicly available but I
cannot find them anywhere else on the FDA website, including the archives. Please help! Here’s the broken link:
https://www.fda.gov/media/144377/download 05/05/2023
inspection of Hubei Meikai Chemical Co., Ltd.., IN MAOSHAN CHEMICAL PARK, PENG SI TOWN, QICHUN COUNTY, HUANGGANG, HUBEI
435099, CHINA (CHN) - Inspection, 2014-07-10 (3008294431). Please send documents as email attachments. 05/30/2023
Please provide the following 1 inspection-related document in electronic PDF format: The EIR (in electronic format) for Human Drugs
inspection of Hubei Meikai Chemical Co., Ltd., IN MAOSHAN CHEMICAL PARK, PENG SI TOWN, QICHUN COUNTY, HUANGGANG, HUBEI
435099, CHINA (CHN) - Inspection, 2016-12-15 (3008294431). Please send documents as email attachments.
inspection of SteriGear, LLC., 30 S MAIN ST, PLEASANT GROVE, UT, 84062-2630, UNITED STATES - Inspection, 2023-03-22 (3007608536).
Please send documents as email attachments.
inspection of Red Medical Solutions, Inc, 427 W MAIN ST STE 8, PATCHOGUE, NY, 11772-3076, UNITED STATES - Inspection, 2023-03-22
inspection of Tesla Biohealing, Inc., 111 MCCOY ST, MILFORD, DE, 19963-2309, UNITED STATES - Inspection, 2023-03-23 (3023229437).
inspection of Tandem Diabetes Care, Inc., 11075 ROSELLE ST, SAN DIEGO, CA, 92121-1204, UNITED STATES - Inspection, 2023-03-23
(3007981285). Please send documents as email attachments.
inspection of AirScan Inc. d/b/a HemaTechnologies., 291 US HIGHWAY 22 STE 6, LEBANON, NJ, 08833-5066, UNITED STATES - Inspection,
2023-03-24 (3003238169). Please send documents as email attachments.
inspection of WAVi Co.., 3459 RINGSBY CT STE 305, DENVER, CO, 80216-4934, UNITED STATES - Inspection, 2023-03-29 (3013757456).
inspection of Mission Systems Davenport Inc., 2734 HICKORY GROVE RD, DAVENPORT, IA, 52804-1203, UNITED STATES - Inspection,
2023-03-30 (3002840531). Please send documents as email attachments. 05/31/2023
inspection of Thrombolex Inc., 75 BRITAIN DR, NEW BRITAIN, PA, 18901-5186, UNITED STATES - Inspection, 2023-03-30 (3015489145).
I'm looking for summary documentation regarding: 510(K) number: BK170004 Tradename: Charter Medical Cell Therapy Fluid Transfer
Set Regulation Number: 864.987 The purpose of this is to review the supporting documentation for the approval of this device. 05/10/2023
I am an investment professional at an asset management firm and would like to request the Summary EIR from the 2/7/2022 –
2/15/2022 inspection for the following facility: Rentschler Biopharma SE Erwin-Rentschler-Strasse 21 Laupheim, Baden-Wuertemburg-
Germany 88471 FEI #: 1000291122 If there is no summary EIR found, please confirm if the inspection has been closed. If possible
delivery in electronic format is requested. 05/19/2023
The name and location of the Inspected Facility and FEI No.: Smithfield Bioscience Inc., located at 12150 Best Pl., Cincinnati, OH 45241 -
FEI No. 1527761. The records being sought correspond with the following inspections: Inspection Dates: 10/27/2016, 05/15/2019, and
07/15/2022. The type of inspection records I am seeking include: All Establishment Inspection Report Summaries related to the above-
described inspection dates. 05/24/2023
Requesting the 483s for the March 31, 2022 inspection of BSP Pharmaceuticals (FEI 3007255826) Via Appia Km 65,561, Latina, Italy by
district ORA 05/30/2023
Good morning, Under the Freedom of Information Act, 5 U.S.C .§ 552, I am submitting a FOIA request to the FDA regarding NDA
214755 (Lumryz - sodium oxybate) to receive copies of the disclosable portions of the following documents: Letter from Jerad G. Seurer
to Nicole Wolanski and Mark Raza, Approval and Orphan Drug Exclusivity for FT218 (sodium oxybate for extended-release oral
suspension) (Jul. 21, 2021) 05/13/2023
214755 (Lumryz - sodium oxybate) to receive copies of the disclosable portions of the following documents: Letter from Debra Y. Lewis
to The Weinberg Group Inc., Designation letter for sodium oxybate, DRU-2016-5302 (Jan. 8, 2018) 05/13/2023
214755 (Lumryz - sodium oxybate) to receive copies of the disclosable portions of the following documents: FDA, Review of Amended
Request for Orphan Drug Designation for sodium oxybate, DRU-2016-5302 (Dec. 21, 2017) 05/31/2023
214755 (Lumryz - sodium oxybate) to receive copies of the disclosable portions of the following documents: Division of Neurology
Products, Sodium Oxybate Consultation Request (Nov. 24, 2017) 05/31/2023
I am requesting the ICSR report source documents from the FAERS Q1 2023 output. The suspect drug is NAXITAMAB. The case numbers
for each report are as follows: 21841964 21958466 21994682 05/19/2023
214755 (Lumryz - sodium oxybate) to receive copies of the disclosable portions of the following documents: Letter from Gayatri R. Rao
to The Weinberg Group, Inc., Deficiency Letter, DRU-2016-5302 (Aug. 23, 2016) 05/13/2023
214755 (Lumryz - sodium oxybate) to receive copies of the disclosable portions of the following documents: FDA, Review of Request for
ODD for sodium oxybate, DRU-2016-5302 (Jul. 28, 2016) 05/13/2023
214755 (Lumryz - sodium oxybate) to receive copies of the disclosable portions of the following documents: Letter from Nicole
Wolanski to Jennifer Gudeman, Sodium Oxybate for the Treatment of Narcolepsy (Jun. 24, 2021) 05/13/2023
214755 (Lumryz - sodium oxybate) to receive copies of the disclosable portions of the following documents: Letter from Jennifer
Gudeman to Sandra Retzky, Orphan Drug Considerations for LUMRYZ (sodium oxybate) for Extended-Release Oral Suspension—DRU
2016-5302 (Aug. 30, 2022)
214755 (Lumryz - sodium oxybate) to receive copies of the disclosable portions of the following documents: Letter from Maria Picone
(TREND Community) to FDA regarding once-nightly oxybate therapy (Nov. 29, 2022) I ask that the information be provided
electronically by email if possible. I approve fees up to $50 before being notified. If the fees are expected to exceed $50, please inform
me before fulfilling my request. Should you deny my request, or any part of the request, please state in writing the basis for the denial.
Please confirm receipt of this request. Kind regards, Annie Nyeste 05/22/2023
214755 (Lumryz - sodium oxybate) to receive copies of the disclosable portions of the following documents: Letter from Jennifer
Gudeman to Janet Maynard, Sodium Oxybate for the Treatment of Narcolepsy (Dec. 8, 2020)
214755 (Lumryz - sodium oxybate) to receive copies of the disclosable portions of the following documents: Letter from John R.
Manthei to Elizabeth Dickinson, Lumryz (sodium oxybate) for extended-release oral suspension (NDA 214755) (Oct. 25, 2021)
Zhejiang Ausun Pharmaceutical Co., Ltd., at No.5, Donghai 4th Avenue, Zhejiang Chemical three most recent establishment inspection
reports (EIRs) for the facility prior to November 9, 2018. • The three most recent Form 483s for inspections conducted at the facility
prior to November 9, 2018.
I would like to receive redacted/anonymized narratives from individual case reports that include a description of I) at least 1 type of
medication error in relation to the drug adapalene, and separate cases mentioning II) 1 type of medication error in relation to
pegfilgrastim. 05/12/2023
RECS RE ALKEM LABORATORIES, ASCEND LABORATORIES
Dear FOIA staff: This is a request under the U.S. Freedom of Information Act, for the request and responsive records produced in
response to FDA request #2021-8192. Please provide the records in electronic format. 05/09/2023
To whom it may concern, Thank you in advance for your help in retrieving data (case report and event/problem narrative) from the
following case id’s: 17536975 19983946 18376743 18284223 19729494 15755170 20472020 9907219 17138396 18277922 05/19/2023
A copy of the Orphan Drug Designation file for sodium oxybate (LUMRYZ), designated on January 8, 2018, and approved on May 1, 2023
(NDA 214755) for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.
We would like two types of records if available: 1. Anything pertaining to the notification of physicians and other prescribers about the
update to the benzodiazepine boxed warning that was issued in September 2020. Perhaps a letter was mailed out? 2. Any evaluation the
FDA has done post-benzodiazepine warning to see if the new labels have influenced prescribing habits for benzodiazepines 05/31/2023
Please share FDA Form 483 for Strides Shasun Limited- Puducherry Formulation Site , Puducherry, India [FEI: 3012448465] inspection
that ended on Feb 24, 2023. 05/19/2023
Copy of the disclosable portions of the EIR for the 12/13/2021 through 12/22/2021 inspection of Koriand'r Williams, M.D. located in
Houston, TX 77077, USA. This inspection pertains to human drugs. 05/11/2023
EIR for the 12/07/2021 through 12/22/2021 inspection of William Sanchez, M.D. located in Miami Lakes, FL 33016, USA. This inspection
pertains to human drugs. 05/10/2023
Request for MedWatch Report for Product Case ID 22129685 Suspect Product: Belimumab; Voclosporin Reaction: Drug Interaction;
Proteinuria Male of unspecified age Country of occurrence: US Manufacturer Control Number: US-GSK-US2023AMR042628 05/19/2023
Dear FOIA staff: This is a request under the U.S. Freedom of Information Act for narrative reports of adverse events received by the FDA
associated with the following case IDs, along with exhibits and/or attachments: 21970474 21901228 21789630 21150665 20984992
20089606 19990136 19459633 19459630 19129218 17852237 15929895 05/19/2023
I am requesting an un-redacted copy of my 510(k). I am the 510(k) holder. The 510(k) number is K092011.
• Request for MedWatch Report for Product Case ID 21925961 • Suspect Product: Voclosporin • Reaction: Death • Unspecified gender
and unspecified age • Country of occurrence: Unspecified • Manufacturer Control Number: N/A 05/19/2023
EIR for the 11/29/2021 - 12/03/2021 inspection of Ausberto B. Hidalgo, M.D. located in Pembroke Pines, FL. This inspection pertains to
human drugs.
EIR for the 11/29/2021 - 12/03/2021 inspection of Ravi K. Moparty, MD located in Spring, TX. This inspection pertains to human drugs. 05/10/2023
K151358
EIR for the 11/23/2021 - 11/23/2021 inspection of Sasidhar P. Kilaru, M.D. located in Cincinnati, OH This inspection pertains to human
drugs. 05/30/2023
Please send a copy of the most recent 2023 inspection report Form 483 for the following company: Sanofi Winthrop Industries, 1051 Bd
Industriel, Le Trait, 76580 France. The site manufactures human drugs and the FEI number is 3003259844.
Requesting the Summary Basis of Approval for NDA 217003 for IMBRUVICA (Ibrutinib) 70 mg/ml Oral Suspension, original approval date
of August 24, 2022.
Redacted submission materials for K160360, Barrx FLEX Energy Generator from Covidien LLC, now owned by Medtronic. Date of
clearance Apr 5, 2016.
K182497 - Medtronic OsteoCool RF Ablation System. We are requesting K182497 because the online summary page per FDA reviewer is
inaccurate. The 510(k) is needed to confirm testing on Bovine liver versus Bovine bone for substantial equivalence.
Redacted submission materials from K120431, Halo 90 Ultra Ablation Catheter, from Barrx Medical, now owned by Medtronic. Cleared
03 May 2012.
K221074 - Stryker OptaBlate RF Ablation System. The 510(k) is needed to confirm testing on Bovine liver versus Bovine bone for
substantial equivalence. 05/30/2023
We are requesting all documents & responses given in response to the following FDA FOIA requests as seen in the April 2023 FDA FOIA
log: 2023-2635, 2023-2638, 2023-2757, 2023-2756, 2023-2889, 2023-2904, 2023-2947, 2023-3102, 2023-3199, 2023-3323, 2023-3336,
2023-3339, 2023-3402 05/08/2023
NDA 16675, Decadron-LA approval, Medical Review, Chemistry Review, Biopharmaceutical and Clinical Pharmacology Review 05/19/2023
We are seeking for full FCN information of FCN 1034. We are willing to pay for the processing of the FOIA request. 05/15/2023
2023-1189, 2023-1199, 2023-1208, 2023-1270, 2023-1297. 05/24/2023
I request disclosure from the Food and Drug Administration a copy of the following records concerning Absolute Standards, Inc., located
at 44 Rossotto Drive, Hamden, CT 06514: Any drug manufacturing applications associated with Absolute Standards; Any records of any
inspections of Absolute Standards; Any complaints received about Absolute Standards. 05/19/2023
All records, reports, information, corrections, correspondence relating to two MAUDE Adverse Event Reports Numbered 1313525-2015-
01507 and 1313525-2015-01508, both involving Trulign Toric Lenses
All records, reports, information, corrections and correspondence relating to two MAUDE Adverse Event Reports, Numbers 2031924-
2014-00344 and..................................................., 2031924-2014-00345, both involving Trulign Toric Lenses
All records, reports, information, corrections and correspondence relating to two MAUDE Adverse Event Reports, Numbers 1313525-
2015-00103 and 1313525-2015-00104, both involving Trulign Toric Lenses.
All records, reports, information, corrections and correspondence relating two MAUDE Adverse Event Reports, Numbers 1313525-2015-
00101 and MW5078061, both involving Trulign Toric Lenses.
Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety
Communication - Please provide all communications and other records of the FDA related to the issuance of this safety communication,
including records and communications that show how the FDA became aware of issues with O&M Halyard Surgical N95 Respirators,
Surgical Masks, and Pediatric Face Masks ETC
All email records for FDA CVM employee David Edwards containing the key search term: AAFCO 12.01.2022-04.30.2023
2018-6019; TESTING RECS
I request all public records that were provided to

Becerra by the Center for Drug Evaluation and Research related to this statement including, but not limited,
reports, memos, emails, letters and talking points re scheduling of Kratom
I hereby request any and all records, documents, or communications prepared or maintained by the FDA pertaining to seizures of
misoprostol and mifepristone from January 1, 2018 to present.
Dear FOIA Officer: Pursuant to the Freedom of Information Act, I request access to and copies of any and all adverse event reports from
consumers about Olaplex brand hair-care and beauty products.
Request for specific assignment memorandum, assignment 'eNSpect Op ID No. 219960. 05/15/2023
I am writing to obtain detailed information regarding the generic version of the drug Prednisone,
produced by Teva Pharmaceuticals’ generics division (AKA Actavis Generics).
Please provide the following 1 inspection-related document in electronic PDF format: The 483 (in electronic format) for Biologics
inspection of CSL Behring L.L.C., 1201 N KINZIE AVE, BRADLEY, ILLINOIS (IL) 60915, UNITED STATES (USA) - Inspection, 2023-03-02
inspection of Loma Linda University Center for Fertility and IVF, FACULTY MED OFFICE LLU CENTER FOR FERTILITY AND IVF, 11370
ANDERSON ST STE 3950, LOMA LINDA, CA, 92354-3400, UNITED STATES - Inspection, 2023-03-02 (3003942532). Please send documents
as email attachments. 05/15/2023
inspection of Thermo Fisher Scientific dba Patheon Biologics LLC, 4766 LAGUARDIA DRIVE, SAINT LOUIS, MISSOURI (MO) 63134-3116,
UNITED STATES (USA) - Inspection, 2023-03-02 (3003418999). Please send documents as email attachments. 05/09/2023
inspection of Southwest Florida Fertility Center, P.A., 15730 NEW HAMPSHIRE CT STE 101, FORT MYERS, FL, 33908-4121, UNITED STATES
- Inspection, 2023-03-08 (3010650553). Please send documents as email attachments. 05/10/2023
Current Label for HIKMA Pharmaceuticals/Actavis Generics’ Prednisone
Current Label for Teva Pharmaceuticals/Actavis Generics’ Prednisone 05/30/2023
inspection of Antibodies Inc, 25242 COUNTY ROAD 95, DAVIS, CA, 95616, UNITED STATES - Inspection, 2023-03-10 (2914537). Please
send documents as email attachments. 05/22/2023
inspection of ABO Plasma Glassboro LLC, 812B DELSEA DR N, GLASSBORO, NJ, 08028-1438, UNITED STATES - Inspection, 2023-03-14
inspection of Alabama Fertility Specialists, PC, 3490 INDEPENDENCE DR, HOMEWOOD, AL, 35209-5604, UNITED STATES - Inspection,
Hi, We are looking for any record of drug related FDA Inspections involving at the UCB plant in Braine-l’Alleaud, Belgium since April 1,
2023? Thank you 05/30/2023
inspection of Summa Health System, 525 E MARKET ST, AKRON, OH, 44304-1619, UNITED STATES - Inspection, 2023-03-21 (1571004).
inspection of Bethesda Fertility Center, 10506 MONTGOMERY RD STE 303, CINCINNATI, OH, 45242-4400, UNITED STATES - Inspection,
1. All documents, including all communications, related to any inspection, investigation, inquiry, or enforcement or compliance action
or proceeding concerning or relating to Seagen Inc.’s (SGEN) facility in Bothell, Washington and its lease for a facility currently under
construction in Everett, Washington. etc
All communications and emails sent or received by FDA related to the letter sent on March 22, 2022 by Raja Krishnamoorthi about the
HeartWare Ventricular Assist Device. https://oversightdemocrats.house.gov/news/press-releases/chairman-krishnamoorthi-requests-
information-from-fda-on-failure-to-regulate
We had an FDA inspection on 10-24 and 10-25 of 2022. We did not receive a final report and our requesting a copy for our records.
Thanks. 05/24/2023
Composition of Polysorbate 20 (CASRN 9005-64-5), including any reference to isosorbide as a congener. A summary of the safety data
FDA reviewed for the determination of Polysorbate 20 as a food additive and the basis for the approved use levels by FDA.
A copy of the approved Prescribing Information/Labeling for Tiopronin Delayed-Release Tablets, 100 mg and 300 mg, approved on
February 24, 2023 under ANDA 217219. 05/30/2023
A copy of the any correspondence from Par Pharmaceutical, Inc. to FDA concerning the marketing status (i.e., discontinuation) and
placement in the Discontinued Section of the Orange Book of Tiopronin Delayed-Release Tablets, 100 mg and 300 mg, approved on
February 24, 2023 under ANDA 217219.
K202184
All communications between the Medical Device Manufacturers Association and the FDA concerning the Mobi-C Cervical Disc.
K200596 G21 Cement Vader Pedicle System
A copy of any records produced by FDA pertaining to the Agency’s April 12, 2023 response to FOIA Control #2023-2408 requested by
McDermott Will & Emery. 05/09/2023
FDA reviewed for the determination of Polysorbate 60 as a food additive and the basis for the approved use levels by FDA. 05/31/2023
P120020, Supera Peripheral Stent System
I am submitting a FOIA request for these 2020 petitions. We need the Petition (and any supplements) as well as FDA’s response (and if
the petition is still open, there is often an “interim response”). We will not need to see the comments filed. FDA-2020-P-1562 FDA-
2020-P-1597 FDA-2020-P-1871
Composition of Sorbitan Monooleate (CASRN 1338-43-8), including any reference to isosorbide as a congener. A summary of the safety
data FDA reviewed for the determination of Sorbitan Monooleate as a food additive and the basis for the approved use levels by FDA. 05/31/2023
Composition of Sorbitan Monostearate (CASRN 1338-41-6), including any reference to isosorbide as a congener. A summary of the
safety data FDA reviewed for the determination of Sorbitan Monostearate as a food additive and the basis for the approved use levels
by FDA. 05/31/2023
Copy of the disclosable portions of the NGE and RAR for the inspection of Medical Vision Ab, located in Nacka, Sweden, for the
inspection ending on 11-07-2019. FEI# 3003647329. This inspection pertains to medical devices.
Copy of the disclosable portions of the NGE and RAR for the inspection of Q-Med AB, located in Uppsala, Sweden, ending date 10-17-
2019. FEI# 3003347293. This inspection pertains to medical devices.
I am submitting a FOIA request for these 2000 petitions. We need the Petition (and any supplements) as well as FDA’s response (and if
the petition is still open, there is often an “interim response”). We will not need to see the comments filed. FDA-2000-P-0240 FDA-
2000-P-0241 FDA-2000-P-0242 FDA-2000-P-0243 FDA-2000-P-0245 FDA-2000-P-0246 FDA-2000-P-0247 FDA-2000-P-0248 FDA-2000-P-
0250 etc
Copy of the disclosable portions of the NGE and RAR for the inspection of Circassia AB, located in Uppsala, Sweden, ending date 09-11-
2019. FEI# 3008662397. This inspection pertains to medical devices.
Copy of the disclosable portions of the NGE and RAR for the inspection of Cochlear Bone Anchored Solutions AB, located in Molnlycke,
Sweden, ending date 10-12-2017. FEI# 3003222064. This inspection pertains to medical devices.
K123563
2021-8137 2020-1392 2019-1430 2017-8479 2017-9214 05/23/2023
CORR, COMPLAINTS RE USE OF BECTON DICKINSON EDTA VACUTAINER TUBES WITH LEAD TESTING
TESTING RECS ETC SIMILAR NEOSURE, ETC 05/11/2023
EMPLOYEE DIRECTORY 05/09/2023

I am requesting access to all warning letters sent to stem cell clinics and regenerative medicine companies related to their violations of
Federal Food, Drug, and Cosmetic Act and its associated regulations and guidance documents from January 1, 2001 to present. In
particular, I am interested in warning letters sent to clinics and companies for violations related to the regulation of human cells, tissues,
or cellular or tissue-based products. 05/09/2023
For Hill's Pet Nutrition, Inc., please provide (1) a copy (if any) of all "For Cause" Inspections and accompanying reports after January 1,
2021; (2) a copy of all complaints and/or correspondence related to any foreign or non-food items found in any canned dog or cat food.
Requesting the EIR report (including the 483s issued) from the following FDA inspection: Respire Medical Holdings Inc 63 Flushing Ave
Unit 303 - Ste 601 Brooklyn NY 11205 Investigator Name: Jacqueline S. Warner
483 issued to TERUMO YAMAGUCHI CORPORATION, in Japan (FEI Number 3013611763) on FDA CDER inspection (230330) 05/30/2023
Please see attached letter. • Any internal communications, memoranda, or other files concerning or discussing Dr. Gatti’s recusal from
consideration of Application Number 205677/S-004. • Any internal communications sent or received by Dr. Gatti concerning Application
Number 205677/S-004.
483 issued to Japan Food Research Laboratories, Saito Japan (FEI Number 3004579906) on FDA CDER inspection (230329) 05/30/2023
unredacted Summary Basis of Approval

(SBA) from the 10/06/2017 for NDA 208,845: Zilretta (Triamcinolone Acetonide
Extended-Release Injectable Suspension 32 mg)(Approval Package issued December 14,
2017). As per transfer of obligation submitted in NDA 208,845/Serial 0299, Pacira
BioSciences, Inc. has acquired Flexion Therapeutics hence we are now the sponsor of this
NDA
human Cronobacter infections in the US since 2001 (referral from CDC)
FAERS report on Pegcetacoplan (SYFOVRE) 05/19/2023
Request for Biopharmaceutics Review(s) (PDF) and Chemistry Manufacturing Control (CMC) Review(s) (PDF) of Reference standard (RS)
Verapamil Hydrochloride Extended-Release Tablets 240 mg, application no. A078906 by applicant holder-Glenmark Generics Ltd. and
Verapamil Hydrochloride Extended-Release Tablets 120 mg and 180 mg, application no. A090700 by applicant holder-Glenmark
Generics Ltd. 05/30/2023
From the Investigational New Drug Application (IND) for Phase 1 Studies of Drug for SKF 81297 (6-chloro-2,3,4,5-tetrahydro-1-phenyl-
1H-3-benzazepine-7,8-diol and/or its salts, CAS #253446-15-0), the sections: 2. Drug Substance [312.23 (a)(7)(iv)(a)]: a. A description of
the drug substance, including its physical, chemical, or biological characteristics; b. The name and address of its manufacturer; etc
ALL FORM 483, EIR, RESPONSE LETTERS, AND ANY OTHER COMMUNICATIONS WITH THE FDA BY/FOR Azurity Pharmaceuticals -LOCATED
AT 8 Cabot Road, Suite 2000, Woburn, MA 01801, Six Concourse Parkway, Suite 1800 Atlanta, GA 30328, 13160 Foster Street, Suite 190,
Overland Park, KS 66213-2689, 841 Woburn Street, Wilmington, MA 01887
inspection of Vi-Jon, LLC, 1 SWAN DR, SMYRNA, TENNESSEE (TN) 37167, UNITED STATES (USA) - Inspection, 2021-07-23 (1025121).
inspection of D. D. Eisenhower Army Med. Ctr. - Blood Bank, 300 E HOSPITAL RD BLDG 300, FORT GORDON, GA, 30905, UNITED STATES -
INSPECTION REPORT QUALGEN, LLC SEPTEMBER 2022 05/12/2023
inspection of Huntington Reproductive Center Medical Group, 20360 SW BIRCH ST STE 200, NEWPORT BEACH, CA, 92660-1534, UNITED
STATES - Inspection, 2023-03-28 (3009565053). Please send documents as email attachments. 05/12/2023
inspection of New York Blood Center, Inc. Donor Center of NYBC, 2791 RICHMOND AVE STE 202, STATEN ISLAND, NY, 10314-5859,
UNITED STATES - Inspection, 2023-03-30 (3005372245). Please send documents as email attachments. 05/10/2023
inspection of AlloSource, 6278 S TROY CIR, CENTENNIAL, CO, 80111-6422, UNITED STATES - Inspection, 2023-03-30 (3000215346).
We are requesting documentation concerning the FDA's clinical review of NDA 216774. 05/23/2023
Please provide the following 1 inspection-related document in electronic PDF format: The Response (in electronic format) for Human
Drugs inspection of Boehringer Ingelheim Fremont, Inc., 6397 KAISER DRIVE, FREMONT, CALIFORNIA (CA) 94555, UNITED STATES (USA) -
Inspection, 2022-11-04 (3005925062). Please send documents as email attachments.
inspection of Boehringer Ingelheim Fremont, Inc., 6397 KAISER DRIVE, FREMONT, CALIFORNIA (CA) 94555, UNITED STATES (USA) -
Inspection, 2022-11-04 (3005925062). Please send documents as email attachments.
Request to acquire FDA 483 for for FDA inspection of M9220 Taizhou Xianju Pharmaceutical - FEI: 3012045665 DUNS 421318816.
Category: Drug Quality Assurance, ending 31 March 2017. Including any previously FOIA released documents related to this inspection. 05/30/2023
Food Contact Notification 2101 Review
Memoranda
I am seeking "certificate of registration of facility" for Himastitva Global Foods Private Limited. The company claims to have USFDA
registration no.16040885360. Please provide record for Food Facility Certificate. 05/12/2023
510 SUMMARY CERTIFIED 05/09/2023

Copy of the disclosable portions of the 510(k) for K181038, CorMatrix CorPatch.
2022-5704, and 2022-5705. 05/23/2023
2022-748, 2020-2345. 05/23/2023
Under the Freedom of Information Act, 5 U.S.C .§ 552, I am requesting copies of any and all submissions and communications between
Reata Pharmaceuticals and the FDA in the last 3 months regarding drug substance impurities and the manufacturing of omaveloxolone
which was recently approved as Skyclarys.
COGENCY GLOBAL INC. hereby requests any information related to the inspection of the Kerry, Inc. facility, located at 320 West Gridley
Road, Gridley, IL 61744-8723 from June 14 to 29, 2018 including, but not limited to: • The establishment inspection report • The
Warning Letter dated July 26, 2018 • etc
Bosutinib Tablets, 100 mg, 400 mg and 500 mg - ANDA 209577 eCTD Sequence 0022 05/19/2023
FDA FAERS reports on pegcetacoplan (brand name SYFOVRE). Please search the database for both drug names. 05/19/2023
510(k) summary for K945952
We would request you to provide case narrative of ISR F198783462 (manufacture's number US-TEVA-2021-US-1955829). The details of
this case of Sweet syndrome (Acute febrile neutrophilic dermatosis) is required to comply with request from a Health Authority. 05/30/2023
Please help us find review reports with NDA#017581 and NDA#018164 for our pharmaceutical development, thanks. 05/19/2023
ADVERSE ANIMAL DRUG EVENT REPORTS 05/18/2023
Subject: FAERS Individual Case Reports Suspect Drug: vigabatrin Case Number Source: FAERS Public Dashboard Case IDs: 12673174
12733250 12776217 12841434 12847221 13032409 13054957 13159499 13242520 13248144 13314872 13375041 05/30/2023
Documents, reports, or communications that reference or include Jorge Morales or Sevrin Morales related to the investigation into Real
Water alkaline branded water products and/or the hepatitis outbreak in Las Vegas, Nevada.
ProPhase Labs, Inc. a United States company, for their headquarters at 711 Stewart Avenue, Suite 200 Garden City, NY 11530 and/or
any associated manufacturing locations or offices. has a webpage located at: https://www.prophaselabs.com 1) Dates of any facility
inspections from 17 August 2018 and forward; 2) Any and all noted observations, objections, and comments during such facility
inspections such as a Form-483 or otherwise, as well as any responses thereto; 3) A list of all ingredients and/or products packed,
handled or stored by Quality Candy that have been subject to, implicated in, or impetus for a recall from 17 August 2018 to present;
ETC
JIF PEANUT BUTTER OUTBREAK RECS
INDIVIDUAL RECS RE DAILY HARVEST OUTBREAK
We are seeking information on pediatric post-marketing studies required from sponsors under PREA. In particular, a number of studies
have missing information on deferral status, whether a deferral extension was issued, the current status of the study, and dates
associated with deferrals, study completion, and study status.
1. All communication with Lennox Intl’ Inc. and Dog Goods USA LLC regarding Salmonella and pig ear dog treats from 2015 through
the present.
2. All communication with Petco Health and Wellness Company, Inc. a/k/ Petco, including Petco Store #1190, regarding Salmonella
and pig ear dog treats from 2015 through the present. etc
I am writing to obtain detailed information regarding the generic version of the drug Prednisone,
produced by Teva Pharmaceuticals’ generics division (AKA Actavis Generics).
Current Label for Teva Pharmaceuticals/Actavis Generics’ Prednisone
Current Label for Teva Pharmaceuticals/Actavis Generics’ Prednisone
All protocols and guidance concerning record retention for communications systems, excluding email. Examples of such systems include,
but are not limited to, WhatsApp, Twilio, Slack, Microsoft Teams, SMS text, Google Workspace, etc. 05/23/2023
Correspondence between the FDA's Center for Drug Evaluation and Research and Stephanie DeChiaro, director of regulatory affairs at
Novo Nordisk, related to drugs Ozempic and/or Wegovy. Please include records that contain the words and/or phrases "weight loss,"
"obesity," "overweight," and "lose weight."
Records generated by reviewer Andreea Ondina Lungu during clinical review of Ozempic (semaglutide, application number 209637), that
mention the words "weight loss," "obesity," "overweight," and/or "lose weight."
Notes and other records generated during and/or following the end-of-phase 2 meeting concerning semaglutide for weight
management (IND 126360) on 10/23/2017.
Advice letter sent to Novo Nordisk on 2/17/2014 regarding development of its phase 3 trial for semaglutide.
All Adverse Events Reports relating to the product "Sterile Talc" (see attached FAERS report). This request includes all underlying
Adverse Events Reports, as well as all other documents (e.g., correspondence, notes, memoranda, reports, analyses, summaries,
notices, reviews) relating to said Adverse Events Reports. 05/19/2023
All Adverse Events Reports relating to the product "Steritalc" (see attached FAERS report).This request includes all underlying Adverse
Events Reports, as well as all other documents (e.g.,correspondence, notes, memoranda, reports, analyses, summaries, notices, reviews)
relating to such Adverse Events Reports.
Quality Assurance Profile (QAP) for Avara Liscate Pharmaceutical Services Spa (FEI#: 3004640070) located at Via Fosse Ardeatine 2,
Liscate, -Select State- 20050, Italy (ITA) 05/19/2023
Establishment Inspection Report, Inspection ID 1192167, for inspection at Gulden Ophthalmics that ended on October 27 2022. Gulden
Ophthalmics would like to obtain a copy of the inspection report for their records. 05/19/2023
current list of all NDCs or ANDAs mapped to the FEI where they are produced.
05/12/2023
Science Corporation seeks Second Sight's Argus II submission: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?
id=h110002 https://www.accessdata.fda.gov/cdrh_docs/pdf11/H110002A.pdf
K162770, Relign System
K212412, IRIS-XP, by Medicore
FOIA Request for Complete 510(k) Bladder EpiCheck by Nucleix Ltd. (K203245) 05/22/2023
Redacted copy of 510k submission for ALADDIN HW 3.0 (510(k) No. K160327) by VISIA Imaging S.R.L.
Records pertaining to any and all radiation-emitting devices or products manufactured by, used by, or within possession of Stereotaxis,
Inc., including but not limited to communications regarding industrial x-ray systems, requests for exemptions under 21 CFR Part 1002,
and the FDA's response(s) to Stereotaxis, Inc.'s February 6, 2002 request.
We request the dates of any Establishment Inspection Reports or Form 483s issued from Sep. 30, 2022 to May 10,2023 for inspections
occurring at 7051 Eagle Blvd, Longmont, CO 80504, which is a drug-related facility owned by Agilent Technologies. Please note that we
are not requesting the form 483s or EIRs. 05/15/2023
We request any Establishment Inspection Reports or Form 483s issued from Sep. 30, 2022 to May 10, 2023 for inspections occurring at
7051 Eagle Blvd, Longmont, CO 80504, which a drug-related facility owned by Agilent Technologies. 05/16/2023
Any and all documents from FDA notifying Alvogen, Inc., Alvogen PB Research and Development LLC, and/or Norwich Pharmaceuticals
that its abbreviated new drug application (ANDA) for Rifaximin tablets cannot be marketed due to either existing patent(s) or exclusivity
related to the reference listed drug, Xifaxan, or 180-day exclusivity related to an ANDA for rifaximin tablets. 05/12/2023
Letter or other correspondence from FDA notifying Alvogen, Inc., Alvogen PB Research and Development LLC, and/or Norwich
Pharmaceuticals that the abbreviated new drug application (ANDA) 214370 for Rifaximin tablets, 200 mg has been granted tentative
approval by FDA. 05/12/2023
Letter or other correspondence notifying Eugia Pharma Specialties Limited and/or Aurobindo Pharma Limited that the abbreviated new
drug application (ANDA) 215123 for Nintedanib tablets has been granted tentative approval by FDA. 05/12/2023
Letter or other correspondence notifying Novartis AG, the Novartis Group, and/or Sandoz Inc. that the abbreviated new drug application
(ANDA) 213713 for Rifaximin has been granted tentative approval by FDA. 05/12/2023
Letter or other correspondence from FDA notifying Sun Pharmaceutical Industries Limited that its abbreviated new drug application
(ANDA) for Rifaximin tablets has been granted tentative approval by FDA.
Letter or other correspondence from FDA notifying Teva Pharmaceutical Industries Limited, Teva Pharmaceuticals USA Inc., and/or
Actavis Laboratories FL, Inc. that its abbreviated new drug application (ANDA) for Rifaximin tablets has been granted tentative approval
by FDA. 05/12/2023
Letter or other correspondence notifying Zydus Pharmaceuticals USA Inc., Zydus Lifesciences Limited, and/or Cadila Healthcare Limited
that the abbreviated new drug application (ANDA) 204947 for Lacosamide tablets has been granted tentative approval by FDA. 05/12/2023
SEDRIC line list for all confirmed
cases of illness, close out summary (to the extent available at this time) and
investigation timeline regarding the 2021 outbreak Listeria monocytogenes outbreak
linked to Dole packaged leafy greens and/or iceberg lettuce.
• FDA, Memorandum, Clinical Superiority of Biogen’s interferon product, Avonex, DRU-1991-627 (Apr. 16, 1996); and • FDA,
Memorandum, Orphan Product Status of BeneFix Coagulation Factor IX (Recombinant) (Jan. 21, 1997); and • FDA, Exclusivity
Memorandum, 09-2887 Signifor LAR (Apr. 3, 2019).
The individual case reports of patients suffering from Interstitial Lung Disease as a result of receiving Enhertu between January 1, 2020
and December 31, 2022 were requested. I will provide the electronic case lists in the EXCEL file later 05/12/2023
inspection of Experimur, A Frontage Company, 4045 S MORGAN ST, CHICAGO, IL, 60609-2514, UNITED STATES - Inspection, 2023-03-10
inspection of JD & SN Inc.,1555 PILGRIM ST, MOSES LAKE, WA, 98837-4623, UNITED STATES - Inspection, 2023-04-04 (3004603767).
inspection of Francis P. Worden, M.D. UNIVERSITY OF MICHIGAN NORTH CAMPUS RESEARCH COMPLEX, 2800 PLYMOUTH RD BLDG 300,
ANN ARBOR, MI, 48109-2800, UNITED STATES - Inspection, 2023-04-04 (3024668724). Please send documents as email attachments. 05/17/2023
inspection of Nelson Laboratories Fairfield, Inc.. 122 FAIRFIELD RD., FAIRFIELD, NEW JERSEY (NJ) 07004, UNITED STATES (USA) -
inspection of PPD Development, L.P. 8551 RESEARCH WAY, SUITE 90, MIDDLETON, WISCONSIN (WI) 53562, UNITED STATES (USA) -
inspection of Eyenovia, Inc. 8748 TECHNOLOGY WAY STE C, RENO, NV, 89521-5925, UNITED STATES - Inspection, 2023-04-05
inspection of Balassa Laboratories, Inc. 509 HERBERT ST, UNIT A, PORT ORANGE, FLORIDA (FL) 32129, UNITED STATES (USA) - Inspection,
inspection of Lornamead Inc.. 175 COOPER AVE, TONAWANDA, NEW YORK (NY) 14150, UNITED STATES (USA) - Inspection, 2023-04-11
inspection of Ash Stevens LLC. 18655 KRAUSE STREET, RIVERVIEW, MICHIGAN (MI) 48193, UNITED STATES (USA) - Inspection, 2022-11-
inspection of American Vape Company LLC.13326 IMMANUEL RD, PFLUGERVILLE, TX, 78660-8006, UNITED STATES - Inspection, 2022-
09-08 (3013057862). Please send documents as email attachments.
Copy of the disclosable portions of the NGE and RAR for the inspection of Respironics, Inc., La Mirada, CA , end date 08-10-2017. FEI#
Copy of the disclosable portions of the NGE and RAR for the inspection of Capillus LLC, Doral, FL , end date 08-09-2017. FEI#
Copy of the disclosable portions of the NGE and RAR for the inspection of Medica Holdings LLC, Lake Oswego, OR , end date 08-08-2017.
Copy of the disclosable NGE and RAR for the inspection of Ormco/Sybronendo, Glendora, CA , end date 07-21-2017. FEI# 2016150. This
inspection pertains to medical devices.
Copy of the disclosable portions of the NGE and RAR for the inspection of Ormco Corporation, San Dimas, CA , end date 07-21-2017.
A listing of all FDA Form 483 Notices of Inspectional Observations for: • Pharmaceutical, biologics and medical device manufacturing
facilities, including premarket approval inspections, AND • Clinical research sites, investigators and IRBs both in the United States and
outside the United States that received such notices dated from April 1 to 30, 2023. etc
A log of all facilities that received a from 483 inspection report for the month of April 2023
Request to acquire the FDA EIR Summary Report and FDA 483 form for FDA inspection of M9110 PharmaZell GmbH - FEI: 3003725792.
Including any previously FOIA released documents related to this inspection. Category: Drug Quality Assurance, ending 22 September
2017. etc 05/30/2023
Any inspection records produced by the FDA for facilities owned by Harrow Health, headquartered at 102 Woodmont Blvd., Suite 610
Nashville, TN 37205. Any inspection records produced by the FDA for facilities owned by ImprimisRx, located at 1705 Route 46 W,
Suites 4 - 6B Ledgewood, NJ 07852 and 1000 Aviara Parkway, Suite 220 Carlsbad, CA 92011
Pacira BioSciences, Inc. is requesting to received the unredacted full Summary Basis of Approval (SBA) from the 10/06/2017 for NDA
208,845; Zilretta (Triamcinolone Acetonide Extended-Release Injectable Suspension 32 mg)(Approval package issued December 14,
2017). As per transfer of obligation submitted in NDA 208,845/Serial0299, Pacira BioSciences, Inc. has acquired Flexion Therapeutics
hence we are now the sponsor of this NDA. 05/23/2023
that led to Sheetz Distribution Services LLC's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver.
that led to OS International, Inc.'s inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver. 05/24/2023
We request a spreadsheet identifying the firms that received FDA Warning Letters between October 1, 2011, and May 1, 2023 or the
most recently available date, to include the following: Company FEI; Company Name; Company Address Line 1; Company Address Line 2;
etc
FDA publishes weekly Enforcement Reports on its website (http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm)

identifying all recalls monitored by FDA once they are classified according to the level of hazard involved. These reports are available as
a downloadable CSV file which includes the following data fields: 1. Product Type 2. Event ID 3. Status 4. Recalling Firm 5. City 6. State 7.
Country 8. Voluntary/Mandated etc
I am submitting a request regarding a formal consultant response from the review division that was referenced in the 10/8/20
Exclusivity Memorandum for the drug REVCOVI™ (elapegademase-lvlr) - BLA#: 761092.
MS PHARMA, QUEBEC, CANADA EIR
that led to Once Again Nut Butter Collective, Inc's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached
Waiver. 05/25/2023
that led to CKK Paradiso, Inc.'s inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver.
that led to Moon Light Burmese Food Corp's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver. 05/24/2023
FDA FOI request for FDA documents, correspondence, letters, memos, related to FDA’s information relevant to the treatment with
ionizing radiation of flour products.
that led to Jasper Wyman & Son's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). 05/24/2023
Pursuant to the Freedom of Information Act, 5 U.S.C. Section 552, and the implementing regulations under 21 C.F.R. Part 20, I hereby
request a copy of the FDA Form 4056 and any other inspection reports for farms in Mexico inspected in connection with the 2023 frozen
strawberry Hepatitis A outbreak.
For the date range October 1, 2022 to May 11, 2023. Please provide all Form 483 and EIR issued at FEI #3014784835. The location is
Wuxi STA Pharmaceutical Co., Ltd located at No. 8 Xinrui Road, Xinwu District, Wuxi, China. The drug product of interest are
CIpaglucosidase Alfa and / or Miglustat. 05/19/2023
I am requesting the Clinical Study (Investigation) Report in its entirety submitted by Alydia Health in 2020 for 510K clearance. Please see
the 510k summary letter attached for further information. The report is in reference to: PEARLE: Prospective, Single Arm, Pivotal
Clinical Trial Designed to Assess the Safety and Effectiveness of the Jada System In Treating Primary Postpartum Hemorrhage (“PPH”)
For the date range October 1, 2022 to May 11, 2023. Please provide all Form 483 and EIR issued at FEI #3010606982. The location is
Wuxi Biologics Co Ltd located at 108 Meiliang Road, Binhu, Wuxi, China. The drug product of interest are CIpaglucosidase Alfa and / or
Miglustat. 05/30/2023
FDA Adverse Event Reporting System (FAERS) listing and detailed results for any submissions on ANDA application ANDA214010, for
lyophilized amphotericin B from TTY Biopharm Company since its approval 05/19/2023
FDA Adverse Event Reporting System (FAERS) listing and detailed results for any submissions on the active ingredient amphotericin B
(UNII: 7XU7A7DROE) since November 1, 2022 05/30/2023
K151987 original submission paperwork needed
All studies, reports, or other records in the agency’s possession that prove, show, or suggest that drug based hiv preventative regimens
commonly known as Prep can delay or prevent hiv tests from being positive when a person is infected with the hiv virus. 05/31/2023
I would like to request the relevant safety and effectiveness record of the 510(k) medical device with the 510(k) number BK220767.
483 issued to Toyobo Co. Ltd. in Japan (FEI Number 1000251214) on FDA CDER inspection (230225) 05/30/2023
Freedom of Information Act (FOIA): Requesting the Agency to provide most recent 3 Form 483 (Notice of Inspectional Observations) of
Teyro Labs Private Limited, with FDA establishment identifier # 3021389808 05/30/2023
I am requesting a complete personnel file along with time off requests for Terrica L Fisher 05/23/2023
records of approval history for each NDA and ANDA approved by the FDA since 01 January 1980, including details about the nature of
specific supplemental approvals (e.g., "SE1," new indication).
inspection meeting minutes, inspection notes, and Form 483 (if issued) related to the inspection: - Feb 01, 2023 inspection of Catalent
Pharma Solutions, LLC in Somerset, NJ related to Human Drugs (FEI # 3003563645) - Jan 24, 2023 inspection of Catalent Maryland Inc in
Harmans, MD related to Biologics (FEI # 3015434301) - Jan 20, 2023 inspection of Catalent Ontario Limited in Windsor, Canada related
to Human Drugs etc
Please provide entry number, customs broker, importer of record and any and all paperwork associated for the entry that caused this
firm to be listed in the FDA import alert for the following detention. Santa Sofia del Sur SAC Date Published : 08/17/2018 Cal. Carret.
Panamericana Norte , Lote 3C El Carmen , Casma-Comandante Noel, Ancash PERU etc
1. All statistics regarding listeriosis diagnoses in North Carolina from August 1, 2021,
to February 28, 2022; 2. All documentation regarding listeriosis diagnoses in North
Carolina from August 1, 2021, to February 28, 2022; 3. All documentation regarding
multistate foodborne outbreak notices relating to Listeria monocytogenes from August
1, 2021, to the present; etc
K942543 510(k) Submission and Acceptance Letter (Sankei Co., Ltd. - Aneroid Sphygmomanometers/mercurial Sphygmomanometers)
All Product Reports from Oct.1,2022 to the date you do the search submitted from 503B compounding facilities as required by Section
503B(b)(2)(A) of the FD&C Act
2022-331, and 2022-1434. 05/24/2023
2022-6365, and 2022-6446. 05/24/2023
2022-7030, 2022-7287. 05/24/2023
2023-1313, 2023-1315, 2023-1316, 2023-1317, 2023-1347 05/24/2023
2023-1400, 2023-1404, 2023-1417, 2023-1431, 2023-1460 05/24/2023
CVs Robert E Davis, Murray Kurzman, Kelly J Pegg, Stacy M Below, etc 05/30/2023
483 issued to Unigen Inc. Ibi-Gun, Japan (FEI 3011033616) on FDA inspection (230310)
Seek any reports of adverse events or serious adverse events as related to the following medicines (GLP-1 agonist): Dulaglutide
Exenatide extended-release Semaglutide Wegovy Mounjaro Ozempic etc 05/30/2023
EIR for the PAI in support of NDA 215887 (8/15/22 – 8/19/2022) Biogen U.S. Corporation 900 Davis Dr Ste B Research Triangle Park, NC
27709
Seeking efficacy & safety subgroup analsyis for Eliquis in A Fib patients cut off age 80 & above & not just > 75 years. Looking for
Hemorrhagic stroke rate in 80 years & above. See medwatch report patient reference AHM-LB-LA.
Twelve individual case reports were requested and their CaseID were shown as following: 21795608 21779740 21772619 21768352
21763130 21762111 21755958 21748762 21741958 21734978 21734476 21723366 05/30/2023
Request for MedWatch report for Kimmtrak case ID 21977527. Suspect Product: Kimmtrak Reaction: Chills;Headache;Blood Potassium
Increased;Nausea;Retching;Renal Failure;Liver Function Test Increased;Abdominal Pain Upper;Haemofiltration;Cytokine Release. Male
of unspecified age. Country of occurrence: US. Manufacturer Control Number: not provided 05/30/2023
FDA-1996-P-0002 FDA-1996-P-0003 FDA-1996-P-0008 FDA-1996-P-0009 FDA-1996-P-0015 FDA-1996-P-0016 etc
In view of submission of our proposed ANDA for PROCHLORPERAZINE MALEATE TABLETS, please provide us the container label and
package outsert of the following RLD- Active Ingredient: PROCHLORPERAZINE MALEATE Proprietary Name: COMPAZINE Dosage Form;
Route of Administration: TABLET; ORAL Strength: EQ 5MG BASE, EQ 10 MG BASE and EQ 25 MG BASE etc 05/30/2023
2023-1463, and 2019-10706. 05/24/2023
Looking for the integrated review for the sparsentan NDA (#216403) Looking for the clinical review docs for sparsentan NDA (#216403)
Looking for all docs reviewing the necessity for liver monitoring for sparsentan NDA (#216403) 05/22/2023
Establishment Inspection Report for the inspection conducted at Axis Clinicals LLC. 1711 Center Ave Dilworth, MN 56529 from
12/12/2022 through 12/16/2022. 05/22/2023
EIR and Form 483 issued to Bachem in 2023 at their site located in Vista, CA. Please note that the recipient may be listed as Bachem or
as a subsidiary called ‘American Peptide Company’ 05/30/2023
The following two (2) CSV files: 1) Listing of all INSPECTIONS since Sunday, May 15, 2022 (in CSV format) with the following fields: FEI
Number, Inspection Start Date, Inspection End Date, Legal Name, Address, City Name, State Code, Zip Code, Country Name, FDA483, Full
Name, District, Center, INSPECTION REASON etc
reports that include a description of I) at least 1 type of medication error in relation to the drug adapalene, and separate cases
mentioning II) 1 type of medication error in relation to pegfilgrastim. 05/30/2023
¿ Exhibits #8, #9, #10, and #11 of LifeVac's 2018 Establishment Inspection Report. ¿ Any subsequent EIR's submitted after 2018 for
this company, FEI #3011053282 05/16/2023
Request for Dr. Reddy's Laboratories Ltd. Srikakulam (FTO SEZ PU2) Form 483 which has 4 observations. Inspection was conducted
between 8th May, 20203 to 12th May, 2023. 05/30/2023
I request the following information as it relates to the unannounced inspection pilot in India in 2022 and 2023: a list of where each
unannounced inspection took place (company name and address of the facility), the dates each inspection was performed, and each
inspection’s designation as OAI, VAI or NAI. I am also requesting a list of where each announced inspection considered a control as it
relates to the pilot in India took place (company name and address of the facility), the dates each inspection was performed and each
inspection’s designation as OAI, VAI or NAI. 05/31/2023
I request true copies of any records of tests or evaluations for the presence and concentrations of pesticide residues and heavy metals
on commercial brands of tobacco products performed or funded in whole or in part by FDA, its Labs, or its contractors during the period
1975 through 2023.
RECS RE GALDERMA RESEARCH AND DEVELOPMENT
BLA FOR QM-114 ETC

INSPECTIONS, CITATIONS
NDA 12071, Decadron Injection: Summary basis of approval, Medical/Clinical Review, Pharmacology/Toxicology Review,
Biopharmaceutical and Clinical Pharmacology Review 05/30/2023
NDA 14694, HEXADROL Injection: Summary basis of approval, Medical/Clinical Review, Pharmacology/Toxicology Review,
Biopharmaceutical and Clinical Pharmacology Review 05/30/2023
NDA 13334, DECADRON W/ XYLOCAINE Injection: Summary basis of approval, Medical/Clinical Review, Pharmacology/Toxicology
Review, Biopharmaceutical and Clinical Pharmacology Review 05/30/2023
all documents and communications relating to any recall of products containing soy flour by Cargill, Inc. for undeclared gluten associated
with Recall Numbers: F-0780-2023, F-0781-2023, F-0782-2023, F-0783-2023, F-0784-2023,etc
All records related to FDA's 11/10/2022 Warning Letter to EarthLab, Inc., dba Wise Woman Herbals (MARCS-CMS 634872).
Requesting a copy of the response letter that you will be sharing with Cipla Ltd. on completion of inspection of its Pithampur, Indore
facility that was inspected from 6th – 17th February, 2023. The company had received 8 inspectional observations in Form 483. Since
the 90 days are nearly over, requesting you to kindly share the status update and final letter issued or that will be issued to the
company.
Please provide the following 1 inspection-related document in electronic PDF format: The Response (in electronic format) for Human
Drugs inspection of PYRAMID Laboratories, Inc..3598 CADILLAC AVE., COSTA MESA, CALIFORNIA (CA) 92626, UNITED STATES (USA) -
Please provide the following 1 inspection-related document in electronic PDF format: The EIR (in electronic format) for Biologics
inspection of Patheon Manufacturing Services LLC 5900 MARTIN LUTHER KING JR. HIGHWAY, GREENVILLE, NORTH CAROLINA (NC)
27834, UNITED STATES (USA) - Inspection, 2022-04-15 (1018495). Please send documents as email attachments.
inspection of Vintage Chemical, Inc., 2007 BREMER ROAD, FORT WAYNE, INDIANA (IN) 46803, UNITED STATES (USA) - Inspection, 2023-
04-12 (3002718545). Please send documents as email attachments. 05/18/2023
inspection of Don A. Stevens, M.D., 3991 DUTCHMANS LN STE 45, LOUISVILLE, KY, 40207-4700, UNITED STATES - Inspection, 2023-04-13
inspection of Wisconsin Medical Radiopharmacy, LLC., 11236 W LAPHAM ST, WEST ALLIS, WISCONSIN (WI) 53214, UNITED STATES (USA)
- Inspection, 2023-04-17 (3004637225). Please send documents as email attachments. 05/19/2023
inspection of Dimensional Merchandising Inc DBA: DMI Personal Care., 86 NORTH MAIN STREET, WHARTON, NEW JERSEY (NJ) 07885,
UNITED STATES (USA) - Inspection, 2023-04-18 (2242642). Please send documents as email attachments. 05/22/2023
I am an investment professional at an asset management firm and would like to requests all form 483s issued in 2023 for the following
facility: UCB Pharma SA Chemin du Foriest Braine-l’Alleud, Belgium, 1420 FEI #: 3003909356 If there are no form 483s found, please
confirm whether this facility has been inspected in 2023. If possible delivery in electronic format is requested. 05/30/2023
Please provide Summary Basis of Approval of MESALAMINE CAPSULE, DELAYED RELEASE ORAL 400MG for the Applicant TEVA
PHARMACEUTICALS USA INC-A207873 05/31/2023
Food and Drug Administration. Workshop on Red Cells Stored in Additive Solution Systems. Bethesda, MD: April 25, 1985.
Seeking a copy of the un-redacted Chemistry Review from the from the original PENSAID 2% NDA 204623 review (review date listed as
26 Jan 2013, corrected version signed by Yong Hu on 01 Feb 2013).
that led to Greenfield Produce Imports, Inc.'s inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver. 05/25/2023
that led to Bullysticks Organic, Inc's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver. 05/25/2023
that led to US Pharmatech's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver.
that led to Advanced Nutrisolutions Corporation's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached
Waiver. 05/24/2023
that led to Euphoria Fancy Food, Inc.'s inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver. 05/25/2023
that led to Swiss-American, Inc.'s inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver. 05/25/2023
that led to Universal Specialty Foods' inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver. 05/25/2023
Copy of the disclosable portions of the 510(k) for K032514, AC Applicator, Aurora AC by Syneron Medical.
Please see attached letter. • Any bioequivalence study or dissolution study data, complete study reports, or summary study reports
submitted during FDA’s consideration of ANDA No. 207098. • Any explanations submitted by the ANDA applicants concerning any failed
studies submitted during FDA’s consideration of ANDA No. 207098. • Any regulatory communications or discipline reviews (excluding
bioequivalence reviews) which discuss the ANDA applicants’ studies, which FDA produced during its consideration of ANDA Nos.
207098.
206890.
207231.
Copy of the disclosable portions of the 510(k) for K202487, Health Joint.
510(k) submission records: K203768 K203774
A copy of the Complete Response Letter sent to scPharmaceuticals, Inc. by FDA regarding scPharma's NDA for FUROSCIX (furosemide). 05/31/2023
Biological Testing Procedures for Fluoride Dentifrices under Docket No. 80N-0042.
We would like to request the files associated with Food Contact Notification (FCN) No. 56, for Food Contact Substance Petroleum
hydrocarbon resins (cyclopentadiene-type), hydrogenated (CAS Reg. Name Naptha (petroleum), light steam-cracked, debenzenized,
polymers, hydrogenated (CAS Reg. No. 68132-00-3), Notifier: ExxonMobil Chemical Company
I am requesting a copy of the Form 483 that was issued by the FDA to Amicus Therapeutics for the FDA’s recently completed pre-
approval inspection of the manufacturing site for its drug cipaglucosidase alfa (AT-GAA). The inspection was completed sometime
between 3/31 – 5/10 and took place at WuXi Biologics Co., Ltd in Shanghai, China. Also, please provide a copy of Amicus’ response (if
available) to the Form 483. 05/31/2023
All files concerning the 510(k) cleared devices referenced on attached first party request letter.
that led to Infinitea Inc.'s inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver. 05/24/2023
Please see attached letter. • Any manuals, technical specifications, or internal training materials concerning the implementation,
maintenance, or use of DAARTS. • Any manuals, technical specifications, or internal training materials concerning the implementation,
maintenance, or use of Panorama.
Please see attached letter. • Any internal communications (including emails, instant or direct messages, records of telephone calls, etc.),
memoranda, or other files concerning or discussing the need for another employee to sign the review for Application Number
205677/S-004 on behalf of Dr. Glass. • Any internal communications sent or received by Dr. Glass concerning Application Number
205677/S-004. • Any internal communications (including emails, instant or direct messages, records of telephone calls, etc.) sent or
received by Dr. Glass concerning Vanda.
Form 483 issued to Dr Reddy's post inspection of the site FTO SEZ PU2 at Srikakulam. The site was inspected between 8-12 May 2023 05/30/2023
Form 483 issued to IPCA Labs following the USFDA inspection at company's Piparia facility. The facility was inspected between 18-26
April 2023. Thanks
Please provide copies of the Center for Tobacco Products (CTP), Office of Science, reviewer's summaries, TPLs, any associated supporting
CTP memoranda or reviewer guides, deficiency letters, and responses to deficiency letters for the following STNs: SE0015386,
SE0016588-SE0016590, SE0016754, SE0016755, and SE0017370.
Requesting all communications between the FDA and the manufacturers of Adderall and Adderall generics and pharmacies related to
the shortage between January 2012 and the present (May15th, 2023).
Pursuant to the Freedom of Information Act (“FOIA”), 5 U.S.C. § 552, I hereby request the production of the following records on behalf
of my client, Jazz Pharmaceuticals Inc.: The orphan drug / clinical superiority consult for NDA 214755 dated August 31, 2021 and
prepared by the Division of Neurology 1 (“DN1”), including any materials appended thereto. 05/22/2023
Allegations of Regulatory Misconduct form submissions. Responsive documents would be those submitted in response to OMB
Control No: 0910-0769, ICR Reference No: 202010-0910-008, Previous ICR Reference No: 201708-0910-001
MISUSE OF OUR COMPANY'S NAME, USFDA NUMBER AND BRAND NAME 1.) Name & address of the importers in the USA 2) Name &
address of the exporters/ shippers from India. 3.) USFDA Registration number used to clear the goods. 4.) Details of the documents
under which the goods were shipped. 5.) The status of the rejected goods, If not destroyed yet, can we have the samples of the product
collected? etc
I am requesting any documents, Establishment Inspection Reports, form 483s, meeting minutes, response letters received, and other
electronic records related to the inspection of Baxter Pharmaceutical Solutions, LLC's facility in Bloomington, Indiana (FEI number
1000115571) on November 10th, 2021 related to the biologics commodity, and also the inspection on February 17th, 2023 related to
human drugs.
A copy of the Approval Package (Summary Basis of Approval) for ANDA 208040 for Dabigatran Etexilate Capsules, 75 mg and 150 mg,
approved on March 11, 2020.
copy of records regarding the orphan-drug exclusivity approval for the following drug product: Drug Name: Vowst (fecal microbiota
spores, live-brpk) BLA Number: 125757 Sponsor: Seres Therapeutics, Inc. Approval Date: 4/26/2023
K211878, LiquiBand XL, by Advanced Medical Solutions. 05/25/2023
On May 11, FDA conducted a video call with various state and local government officials on the topic of the Regualtion of Cannabis-
Potential Pathways Forward. It was hosted by Patrick Cournoyer of FDA. CRN requests a copy of the audio and video recording of that
session and a transcript of the session, including any Q&A that occurred. CRN also requests a copy of all slides used in that presentation.
Freedom of Information Act (FOIA) request for FDA inspections
Freedom of Information Act (FOIA) request for FDA Inspections
As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483:
Cambrex Charles City Inc Charles City, Iowa United States End Dates of inspection: 02 May 2022 Project Area: Drug Quality Assurance
FEI: 1000119390 Classification: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request, however please
contact me if the charges exceed $ 200. 05/22/2023
Christine H. Lee, M.D. Victoria Canada End Dates of inspection: 17 Jun 2022 Project Area: Bioresearch Monitoring FEI: 3009256939
Classification: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request, however please contact me if the
charges exceed $ 200.
Deseret Laboratories, Inc. Saint George, Utah United States End Dates of inspection: 18 Nov 2022 Project Area: Drug Quality Assurance
FEI: 1000160324 Classification: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request, however please
Michael J Rosen MD Cleveland, Ohio United States End Dates of inspection: 01 Mar 2023 Project Area: Bioresearch Monitoring FEI:
3012549482 Classification: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request, however please
Copy of the disclosable portions of the NGE and RAR for the inspection of Suntech Medical, Inc., Morrisville, NJ , end date 07-13-2017.
Copy of the disclosable NGE and RAR for the inspection of Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical, Orange, CA , end
date 07-12-2017. FEI# 2024312. This inspection pertains to medical devices.
Copy of the disclosable NGE and RAR for the inspection of Kimberly-Clark Corporation, Neenah, WI , end date 06-23-2017. FEI#
Copy of the disclosable NGE and RAR for the inspection of Alpha Teknova Inc, Hollister, CA , end date 06-21-2017. FEI# 3012652927. This
Copy of the disclosable NGE and RAR for the inspection of Dornoch Medical Systems Inc, Riverside, MO , end date 06-02-2017. FEI#
To this end we are collecting various data to which we would like to gain access: Data on API imports.
I'm requesting all phone records and calendar records from FDA officer Michael Morgan ORA FDA DSWI McAllen TX.
(Michael.Morgan1@fda.hhs.gov)
I'm requesting all phone records and calendar records from FDA officer Adrian De La Rosa ORA FDA DSWI McAllen TX.
(Adrian.DeLaRosa@fda.hhs.gov)
E-mail records from Mark Guerra (Mark.Guerra@fda.hhs.gov) and Virginia Ramos (VIRGINIA.RAMOS@fda.hhs.gov) pertaining to
keywords (included in the document)
2014 Establishment Inspection Report of Kramer Laboratories
FDA’s correspondence with Pharmakon Pharmaceuticals, dated June 9, 2014 and August 25, 2014, which are referenced in FDA Detroit
District Office’s May 21, 2015 Warning Letter to Pharmakon Pharmaceuticals (2015-DET-12). Please include all attachments and exhibits
to the aforementioned FDA correspondence.
clinical review summary basis of approval Flonase, 1994 NDA Approval 05/30/2023
Bosutinib Tablets, 100 mg and 500 mg - ANDA 209577 eCTD Sequence 0023 . Please include index.xml 05/19/2023
A copy of any 483 inspection materials between February 1st 2023 through May 16th 2023 at the following site: FEI 3003909356 UCB
Pharma, Address: CHEMIN DU FORIEST, BRAINE-L'ALLEUD, 1420, BELGIUM (BEL). *Please send electronic copies of any material if
possible. 05/30/2023
[Reference FGI#23-82867] Relevant to GS35F0244R Order 75F40119A10009 we seek
• Contract
• Solicitation/RFP
• Statement of Work (SOW)
ANDA 212789 - Sodium Picosulfate, Magnesium Oxide, and Anhydrous Citric Acid for Oral Solution, 10 mg/3.5 g/12 g per Pack. Hetero
Labs Ltd. SBOA (Summary Basis of Approval). RLD -Prepopik for Oral Solution, 10 mg/3.5 g/12 g per Packet, Ferring Pharmaceuticals Inc.
(NDA #202535)
Please provide the following 1 inspection-related document in electronic PDF format: The 483 Response (in electronic format) for the
Biologics inspection of SpringCreek Fertility located in Centerville, OH United States - Inspection ending 2023-01-05 (FEI 3011408185).
Summary Basis of Approval for Aponvie (aprepitant) injectable emulsion 32MG/4.4ML (7.2MG/ML). (NDA# 216457) held by Heron
Therapeutics, Inc 05/22/2023
Summary Basis of Approval for APONVIE (Aprepitant) injectable emulsion 32MG/4.4ML (7.2MG/ML), (NDA# 216457) held by HERON
THERAPS INC 05/22/2023
caseid and drugname were attached in PDF file
¿1¿Copy of the disclosable portions of the 510(k) for K222547, Electric nasal aspirator by Shenzhen XinLianFeng Technology CO.,LTD.
¿2¿Copy of the disclosable portions of the 510(k) for K090379, AVITA NASAL ASPIRATOR(MODEL NS1 SERIES) by AVITA CORPORATION.
A complete record of any and all consumer complaints submitted to FDA that reference "smelling salt", "Nose Slap", or "Soul Slap",
including but not limited to the date of submission to FDA, complete text of the complaint, and any and all information provided by the
submitting party, including Reporter Name.
Please provide the following 1 inspection-related document in electronic PDF format: The 483 (in electronic format) for the Human
Drugs inspection of Bret R. Rutherford, M.D. located in New York, NY, US - Inspection ending 2023-01-10 (FEI 3023259471). Please send
documents as email attachments. 05/25/2023
Drugs inspection of Miyoshi America, Inc. located in Dayville, CT, US - Inspection ending 2023-01-13 (FEI 3009481791). Please send
Drugs inspection of Ferring Pharmaceuticals Inc located in Parsippany, NJ, US - Inspection ending 2023-03-14 (FEI 1000119907). Please
send documents as email attachments.
Drugs inspection of Rentschler Biopharma Inc. located in Milford, MA, US - Inspection ending 2023-03-24 (FEI 3003282293). Please send
Please provide the following 1 inspection-related document in electronic PDF format: The 483 (in electronic format) for the Biologics
inspection of CSL Plasma Inc. located in Hazel Crest, IL, US - Inspection ending 2023-03-29 (FEI 3010806993). Please send documents as
email attachments.
inspection of Lisa A. Clough, M.D. located in Kansas City, KS, US - Inspection ending 2023-04-18 (FEI 3025549963). Please send
Please provide the following 1 inspection-related document in electronic PDF format: The 483 (in electronic format) for the Medical
Devices inspection of Eurofins Viracor, LLC. located in Lenexa, KS, US - Inspection ending 2023-04-19 (FEI 3005651716). Please send
documents as email attachments.
inspection of Christopher T.F. Huang M.D., Inc. dba Advanced Reproductive Center of Hawaii located in Honolulu, HI, US - Inspection
ending 2023-04-28 (FEI 3013057862). Please send documents as email attachments.
Biologics inspection of Regents of the University of California on behalf of UCLA Fertility and Reproductive Health Center, located in Los
Angeles, CA, US - Inspection ending 2023-01-11 (FEI 3009655178). Please send documents as email attachments. 05/22/2023
All email records for FDA CVM employee Charlotte Conway containing the key search term: AAFCO. (Date range for records search is:
01.01.2023-01.31.2023) 05/18/2023
Requesting records for: 1. All reports of adverse events and/or reactions dog and/or cats have had to dog and cat food and dog and cat
treats from 12.01.2022-12.31.2022. a. Please include the type of animal, the reaction, the brand name and the product name of the
food item to which the dog or cat reacted, the symptoms displayed and the outcome, if available. etc
I'm requesting all calendar records for Earl Echon 01.01.18-12.31.18. FDA already performed a search for these records for 2019-5044 05/30/2023
All communications to and from Method Pharmaceuticals, LLC, including communications between the FDA and individuals with the
email domain "@methodpharm.com" including but not limited to tucker.scott@methodpharm.com; diggs@methodpharm.com;
boone.chris@methodpharm.com; rosenthal.andrew@methodpharm.com; tucker.danielle@methodpharm.com;
bartel.brett@methodpharm.com etc
Inspection citation Records
Records and communications of the Center for Biologics Evaluation and Research (CBER), FDA, regarding assessing blood donor
eligibility using a set of individual risk-based questions to reduce the risk of transfusion-transmitted HIV, specifically: 1) proposed
individual risk assessments or risk assessment questions. 2) proposed Donor Health Questionnaire (DHQ).etc
information, communications, announcements, submissions, materials, and/or other relevant data related to the Food and Drug
Administration (FDA) voluntary recall for Event ID: 92013 (Prosante® Textured Soy Flour & Prolia® Soy Flour).
I am looking for any and all food/health inspection reports on the restaurant named, Paco’s Tacos Incorporation, located on 4311 S
Archer Avenue in Chicago, IL 60632.
that led to Onkar Enterprises' inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver. 05/24/2023
that led to Yates Mushroom Co., Inc's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver. 05/25/2023
that led to Permaglow Inc's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver. 05/25/2023
Pursuant to the Freedom of Information Act (FOIA), 5 U.S.C., we hereby request a copy of the submission associated with Merlin Plastics
Supply, Inc.’s Letter of No Objection (LNO) 286 and all FDA chemistry and toxicology review memoranda documenting the Agency’s
review of the information in support of LNO 286. 05/31/2023
I am requesting a copy of the FDA Form 483s issued to American Infertility of New York P.C., a fertility clinic in New York. The FDA issued
a 483 to this clinic on Jan. 14, 2015, and another one on March 3, 2017.
REPORTS OF CONTAMINATION, INJURY, BACTERIAL SICKNESS FOR SIMILAC NEOSURE FORMULA LOT 05/17/2023
RMSA REPORTS SUBMITTED TO NARA LAST FIVE YEARS 05/23/2023
2021/2022 E. coli O157:H7 outbreak referenced in the January 6, 2022 report and specifically those records pertaining to Josie’s
Organics
2020-3834 and 2020-5883 05/31/2023
Hello FOIA Experts! I'm requesting the full available documentation related to K213794.
A theft occurred on the project site at the FDA Forensic Chemistry Center at 6751 Steger Dr, Cincinnati Ohio between 2:00PM on
5/15/23 thru 7:30AM on 5/16/23. The location of the theft is believed to be covered by the security systems. We would like to obtain
this video evidence as part of this investigation. 05/17/2023
FDA Foreign Supplier Verification Programs. We request a spreadsheet which includes the 23 publicly available data points for all
entries that led to Tianyi International Trade Inc's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached
Waiver. 05/25/2023
that led to Ray & Mascari, Inc's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver. 05/25/2023
" On the publicly available FDA site: https://www.fda.gov/media/119312/download, FDA provides a list of companies participating in
the FDA Foreign Supplier Verification Programs. We request a spreadsheet which includes the 23 publicly available data points for all
entries that led to Be Leaf Corporation's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver." 05/25/2023
" On the publicly available FDA site: https://www.fda.gov/media/119312/download, FDA provides a list of companies participating in
the FDA Foreign Supplier Verification Programs. We request a spreadsheet which includes the 23 publicly available data points for all
entries that led to C. Liberatore, LLC's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver." 05/25/2023
that led to De Sol Corp's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver. 05/25/2023
"On the publicly available FDA site: https://www.fda.gov/media/119312/download, FDA provides a list of companies participating in the
entries that led to International Food Distributors DBA APB & M Corp's inclusion in this list for the last 2 years (April 1, 2021 - April 30,
2023). Please include both the legal name and dba name in the search results. See attached Waiver." 05/25/2023
We request a spreadsheet which includes the 23 publicly available data points for all entries that led to Conchita Foods, Inc.'s
inclusion in this list for the last two years (April 1, 2021 - April 30, 2023)" 05/26/2023
We request a spreadsheet which includes the 23 publicly available data points for all entries that led to Delicias Import, Inc.'s inclusion
in this list for the last 2 years (April 1, 2021 - April 30, 2023). " 05/25/2023
that led to Fourstar Group USA, Inc.'s inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver. 05/25/2023
510(k) Premarket Notification for K093479
Inspection report and FDA form 483 for Patheon (Thermo Fisher Scientific) - Cincinnati, OH (FEI # 1510437) for inspection performed in
April 2023
Drugs inspection of SOFIE Co. dba SOFIE located in Somerset, NJ, US - Inspection ending 2023-01-20 (FEI 3005705951). Please send
inspection of University Reproductive Associates, P.C. located in Hasbrouck Heights, NJ, US - Inspection ending 2023-01-19 (FEI
3005187588). Please send documents as email attachments.
Drugs inspection of Packaging On Demand, Inc. located in San Clemente, CA, US - Inspection ending 2023-01-13 (FEI 3004758248).
Devices inspection of Sri Sundaram, M.D. located in Littleton, CO, US - Inspection ending 2023-01-13 (FEI 3014965862). Please send
Drugs inspection of Steven D. Folkerth, M.D. located in Dayton, OH, US - Inspection ending 2023-01-13 (FEI 3004779351). Please send
inspection of University Reproductive Associates, P.C. located in Hasbrouck Heights, NJ, US - Inspection ending 2023-01-19 (FEI
3005187588). Please send documents as email attachments. 05/22/2023
Drugs inspection of CofixRX, LLC located in Rochester Hills, MI, US - Inspection ending 2023-01-20 (FEI 3021350094). Please send
Aurobindo would like to request the following documents from the Summary Basis of Approval (SBOA) for
GLYDO(LIDOCAINE HYDROCHLORIDE) Jelly 2%, Application Number: A201094:
1) Administrative review
2) Chemistry review
that led to International Food Products Corporation's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached
Waiver. 05/25/2023
Aurobindo would like to request the following documents from the Summary Basis of Approval (SBOA) for
XYLOCAINE (LIDOCAINE HYDROCHLORIDE) Jelly 2%, Application Number: N008816:
1) Administrative review
2) Chemistry review 05/30/2023
that led to Lipari Foods Operating Company LLC's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached
Waiver. 05/26/2023
K183311 -- We are requesting the full 510(k) Premarket Notification Submission file for Invenix Infusion System (IIS), K183311, including
any Additional Information Requests and Applicant Responses
FDA-1986-P-0003 FDA-1986-P-0010 FDA-1986-P-0011 FDA-1986-P-0015 FDA-1986-P-0018 FDA-1986-P-0019 etc
FDA-1985-C-0553 FDA-1985-P-0001 FDA-1985-P-0017 FDA-1985-P-0026 etc
Drugs inspection of Luis Pena-Hernandez, M.D. located in Atlantis, FL, US - Inspection ending 2023-01-23 (FEI 3024611819). Please send
Drugs inspection of Banji Awosika, M.D. located in Orlando, FL, US - Inspection ending 2023-01-27 (FEI 3024050736). Please send
Drugs inspection of Antonio E. Blanco, M.D. located in Miami, FL, US - Inspection ending 2023-01-30 (FEI 3015928879). Please send
Drugs inspection of Verde Cosmetics Labs, LLC located in Northridge, CA, US - Inspection ending 2023-02-09 (FEI 3014015976). Please
FGI requests from the FDA all text messages sent or received and all phone logs within the date range of Dec 12, 2022, until the day the
search begins for the following FDA officials: • Robert M. Califf, Commissioner • Patrizia Cavazzoni, Director, Center for Drug
Evaluation and Research • Susan T. Mayne, Director, Center for Food Safety and Applied Nutrition • Brian King, Director, Center for
Tobacco Products • etc
The following records concerning Contract 75F40118D10020 awarded to Acumen LLC
The following records concerning Contract 75F40118D10022 awarded to International Business Machines Corporation:
The following records concerning Contract 75F40120D00028, awarded to CVS Health Clinical Trial Services LLC
The following records concerning Contract 75F40118D10053 awarded to International Business Machines Corporation
The following records concerning Contract 75F40120D00011 awarded to IQVIA Government Solutions, Inc
The following records concerning Contract 75F40120D00026 awarded to The Lewin Group, Inc
The following records concerning Contract 75F40120D00027 awarded to IQVIA Government Solutions, Inc:
All email attachments for the records provided in response to FOIA Request #2022-7567 submitted to FDA on October 24, 2022, and
responded to by FDA on January 20, 2023.
All copies of the safety and immunogenicity comparison analyses and studies conducted concerning Pfizer vaccine manufactured using
“Process 1” and “Process 2” as referenced in the final clinical trial protocol.
All documents submitted by Pfizer and Moderna to the FDA as part of the Chemistry Manufacturing Controls (CMC) Module for the
Biologics License Application for their respective COVID-19 vaccines.
Copy of the disclosable portions of the 510(k) for DEN200069, Cognoa ASD Diagnosis Aid.
Please open the Form 483 (Notice of Inspectional Observations) - Company name: Hugel, Inc. (FEI 3012163998)
- Address: 23, Geodudanji 1-gil, Dongnae-myeon, Chuncheon-si, Gangwon-do 24398, Korea, South (KOR)
- On-site inspection date: March 2023
05/30/2023
Prometheus would like to request the FDA's Approval Package (including Review) for the SUPPLEMENT BLA APPROVAL for Remicade
(Infliximab) - Application Number: BLA 103772/5301.
A list of all medical devices that have undergone cybersecurity review. Data include the device's name, manufacturer, date of review,
and class of device.
We apply for complete review report for ANDA 205660 Enoxaparin sodium injection which was approved in March of this year. The
review report may include several parts, such as CMC, BE, labeling and we prefer to apply for the complete report. But if we have to
apply for one part per time, we prefer to have CMC part.
We would need to receive 1) a full list of approved and/or launched drug products based on drug-drug cocrystals (DDCs or multidrug
cocrystals MDCs) such as Seglentis (tramadol/celecoxib). The list should not contain API-coformer co-crystals nor FDCs (fixed dose
combination) 2) a full list of approved and/or launched FDCs.
I am requesting data from FDA’s records to find out a "rate of clearance/approval" (=workload/#approved applications) of successful
applications which gain clearance or approval with FDA. Currently, I have only found the on-time success rates for meeting MDUFA,
PDUFA, etc. through the performance reports.
Copy of the disclosable portions of all emails, including attachments, identifying the one biologics application listed in the table titled
“Delayed Application Decisions Solely due to Pending Inspection or Facility Assessment” on page 8 of FDA’s Resiliency Roadmap for FDA
Inspectional Oversight dated May 2021.
We are requesting information on "Nature’s One’s (brand name)- the official firm name is “Nat2 Inc”. The FEI number is 3016994738.
https://datadashboard.fda.gov/ora/firmprofile.htm?FEIs=3016994738 The Database shows they had an inspection (inspection ID
1194101) on 12/2/2022. We are requesting the copy of the 483 report from the 12/2/2022 inspection. 05/22/2023
LIFECELL CORR
I would like any inspection records (483s) for the 10819 Gilroy Rd, Hunt Valley, MD facility of Pharmaceuticals International Inc.
Specifically only for inspections that occurred in 2023. Thank you! 05/30/2023
Request for copy of EIR Lonza 14905 Kirby Drive Houston, TX 77047 USA FEI # 3013629214 Inspection Conducted in February 2022
I would like to know about abnormal behaviors and cognitive changes, such as depression, suicidal ideation, homicidal ideation, anger,
and hallucinations that may be related to the usage of albuterol HFA 108 (90 BASE) mcg/ACT oral inhaler in adolescents aged 10-19. 05/30/2023
that led to All Points Manufacturing, LLC's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver. 05/25/2023
entries that led to Facema LLC's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver.
510(k) Premarket Notification for K122619.
EIR and related documents for Inspection Conducted in December 2020 Lonza 14905 Kirby Drive Houston TX FEI 3013629214 05/31/2023
entries that led to Transu Investment Group, LLC's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached
Waiver.
entries that led to Franmar Distributors, LLC's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached
Waiver.
entries that led to El Molino Bakery Supplies, Inc.'s inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached
Waiver.
entries that led to Advanced Food Concepts' inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver.
that led to the inclusion of Greenbrier International and its affiliates in this list for the last 2 years (April 1, 2021 - April 30, 2023).
entries that led to Casa Rovigatti's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver."
entries that led to S&M Professionals's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). This firm also does
business as Savory Prime - please include results for both names. See attached Waiver."
entries that led to First World Imports, Inc.'s inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached
Waiver."
Written training materials - such as slides, documents, and articles - currently used in the Office of Chief Counsel new attorney training
program.
Could you please provide us the documents for K070136. Thanks!
FDA Form 483 issued in 2019 to the following company: Zochem ULC 1 Tilbury Court Brampton, ON L6T 3T4 Canada 05/30/2023
Individual Case Safety Report Request Primary Suspect Drug: Albumin Human/Certolizumab Pegol. Secondary Suspect Drug: Allergenic
Extract- Insect Venom/ Histamine Source: FAERS Q4 2022 Quarterly Data File Case Number: 16742709/ 21166268 05/30/2023
Please provide the following 1 inspection-related document in electronic PDF format: The 483 Response Letter (in electronic format) for
the Human Drugs inspection of CareFirst Specialty Pharmacy LLC located in Mount Laurel, NJ, US - Inspection ending 2022-11-30 (FEI
3012258924). Please send documents as email attachments. 05/26/2023
Drugs inspection of ScieGen Pharmaceuticals, INC. located in Hauppauge, NY, US - Inspection ending 2023-04-21 (FEI 3008298016).
inspection of Berkshire Sterile Manufacturing, Inc. located in Lee, MA, US - Inspection ending 2023-01-20 (FEI 3012144557). Please send
inspection of Rosa M. Suarez, M.D. located in Miami, FL, US - Inspection ending 2023-03-10 (FEI 3012222837). Please send documents as
email attachments.
inspection of MiMedx Group, Inc. located in Marietta, GA, US - Inspection ending 2023-03-02 (FEI 3005897621). Please send documents
as email attachments. 05/24/2023
inspection of MiMedx Group, Inc. located in Kennesaw, GA, US - Inspection ending 2023-03-02 (FEI 3009814715). Please send
Devices inspection of Klarity Medical Products LLC located in Heath, OH, US - Inspection ending 2023-02-16 (FEI 3001236129). Please
Devices inspection of Phoenix Deventures located in Morgan Hill, CA, US - Inspection ending 2023-02-15 (FEI 3008514120). Please send
inspection of Osteolife Biomedical I LLC located in Miami, FL, US - Inspection ending 2023-02-14 (FEI 3014623896). Please send
Lidocaine Injection - ANDA 218071 - eCTD seq 0001 05/19/2023
FDA Form 483 issued in 2019 to the following company: Zochem ULC 1 Tilbury Court Brampton, ON L6T 3T4 Canada 05/22/2023
PMTA MDO ENDs related to Shenzhen Yibo Technology Co., Ltd. (d/b/a ZLab; Ziip Lab; Ziip-Lab; ZiipLab).
Drugs inspection of Merrill K. Shum, M.D. located in Whittier, CA, US - Inspection ending 2023-02-15 (FEI 3025160675). Please send
Annual number of tobacco retailers in California that received citations for public nuisance, over the past year and past five years if
available - Annual number of smokers in California who have received public nuisance citations for smoking in non-smoking areas, past
year or past five years if available etc
Hello, Good afternoon. Please provide all emails between Billy Dunn and any addresses that include "prothena"
To Whom It May Concern: Pursuant to the Freedom of Information Act, I hereby request the following records: Agenda, meeting
minutes, presentations, handouts, transcript, a list of participants from the June 2, 2021 meeting between the American Society of
Health-System Pharmacists (ASHP) and Peter Marks of the FDA.
Records related to the HeartMate 3 Left Ventricular Assist System, a Class 3 medical device, PMA Number P160054, and the device
manufacturer, Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, California 94588: All Inspection records for Thoratec
Corporation in Pleasanton, CA, including Forms 483 (Notice of Inspectional Observations), etc
Under the Freedom of Information Act, 5 U.S.C .§ 552, I request an electronic copy of all FDA communication and review documents
related to Auvelity's approval for BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE.
Copy of the disclosable portions of a list in a csv format of all FDA-conducted inspections from 01/01/2020 to the present. Please
indicate the inspection end date, FEI number, Project Area, and CPGM Program Assignment Codes. 05/23/2023
January 1, 2020 to
present related to: 1) Form 483s issued by the FDA to Catalent for their plants in Brussels, Belgium and Bloomington, Indiana
2) Written responses within 15 working days from Catalent to the FDA to the above Form 483s etc
I would like the information available regarding the applicant pool for the opening:
FD/CFSAN/OCD Supervisory SBRBPAS Expert, 0403. The announcement came out January 3,
2023, and closed January 17, 2023, from CFSANExecutiveRecruitment@fda.hhs.gov
Carolina Egg Company/Braswell Family Farms, 10927 Cooper Road, Nashville, North Carolina 27856, Kreher Family Farms, 5411 Davison
Rd, Clarence, NY 14031, Hillandale-Gettysburg, 3913 Oxford Road, New Oxford, Pennsylvania 17372 etc - inspections, etc
Records and communications of Emily Thakur, CDR, United States Public Health Service, Team Leader, Drug Shortage Staff (DSS), Center
for Drug Evaluation and Research (CDER), FDA including emails, email chains, email attachments, text messages, meeting voice
recordings, correspondence, statements, letters, memoranda, reports, presentations, notes, or other form of record regarding: 1)Drug
supply shortages resulting from raw materials, active pharmaceutical ingredients and / or components from suppliers that originate
outside the U.S. etc
Records and communications of Emily Thakur, CDR, United States Public Health Service, Team Leader, Drug Shortage Staff (DSS), Center
for Drug Evaluation and Research (CDER), FDA including emails, email chains, email attachments, text messages, meeting voice
recordings, correspondence, statements, letters, memoranda, reports, presentations, notes, or other form of record regarding: 1)Drug
supply shortages resulting from raw materials, active pharmaceutical ingredients and / or components from suppliers that originate
outside the U.S. etc
entries that led to Nature's World Harvest's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached
Waiver."
entries that led to Sun Commodities, Inc.'s inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver.
Please include data for Sun Commodities, Inc. (including, but not limited to, DUNS number 012073990) and affiliates - Sun Group of
Companies; Sun City Produce (including, but not limited to DUNS 012073990); Sun International; Global Maritime."
entries that led to Pepe's Foods, Inc.'s inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver."
Rich Products is requesting data for the following sites they own/operate: Rich Products Corporation, 1150 Niagara St., Buffalo NY
14213, (including but not limited to DUNS: 00-210-8371); RICH-SEAPAK CORPORATION, 08-009-5094, 1867 DEMERE RD, SAINT SIMONS,
ISLAND, GA, 31522-2804; GOGLANIAN BAKERIES, INC., 12-229-5736, AKA: GOGLANIAN, etc
entries that led to Best Food Suppliers Corp's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached
Waiver."
that led to Taza Trading Inc.'s inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver.
that led to Daiso California LLC's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver.
entries that led to Terry Laboratories Inc's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver.
entries that led to Carib Import & Export, Inc.'s inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached
Waiver.
entries that led to Bak Foods, LLC's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver.
Purolite is seeking a disclosable portion of the food contact notification FCN 74 (LANXESS Corporation) and FCN 254 (DDP Specialty
Electronic Materials US 5, LLC) regarding the chemical, migration, extraction testing, dietary exposure assessment, and any toxicology
data that may be present especially related to residual monomers/low molecular weight oligomers. etc
Please provide Summary Basis of Approval of HYDROCORTISONE SODIUM SUCCINATE (SOLU-CORTEF) INJECTABLE INJECTION EQ
100MG BASE/VIAL,EQ 250MG BASE/VIAL,EQ 500MG BASE/VIAL,EQ 1GM BASE/VIAL for the Applicant PHARMACIA AND UPJOHN CO-
N009866 05/30/2023
We are indicated on the FSVP list as an importer of record. I am auditing our FSVP program and would like a of list entries for which we
are designated as the FSVP importer.
Drugs inspection of Fayz A. Hudefi, M.D. located in Bentonville, AR, US - Inspection ending 2023-04-21 (FEI 3016580854). Please send
Please provide disclosable portions of the original FOIA request letters and complete FDA responses for file numbers 2023-3341, 2023-
1175 & 2023-1178.
Requesting a copy of the DN1 consult for Lumryz/FT218 (NDA No. 214755) dated August 31, 2021, which is referenced as an addendum
to the DN1 consult for Lumryz/FT218 dated May 1, 2023. 05/31/2023
Please provide the disclosable portions of the original request letter and page count for the entire fulfillment for File numbers: 2023-
745, 2023-844, 2023-1248 & 2023-1591
Please provide copies of the disclosable portions of the Center for Tobacco Products (CTP), Office of Science, reviewer’s summaries,
TPLs, and any associated supporting CTP memoranda or reviewer guides for the following STNs: SE0017162, SE0017158, SE0017155,
SE0017153, SE0017152 and SE0017151.
Establishment Inspection Report (EIR) for the FDA Form 483 (483) for the FDA Inspection of SMS Pharmaceuticals Limited (FEI Number
3003971663) facility in Telangana, India ending on March 5, 2020.
I am writing to request, under the Freedom of Information Act, the following FDA Adverse Event Reporting System (FAERS) records,
noted below by case number, pertaining to the drug Leqembi (brand name) or lecanemab (generic): 22137054 22110894 22131771
22053964 21911314 22108262 22086275 20453079 22035372 22001710 21903025 22018092 Thank you for your assistance. 05/23/2023
noted below by case number, pertaining to the drug Leqembi (brand name) or lecanemab (generic): 21959204 21904959 21899859
21899077 21856064 21828248 21361672 21308837 20754994 20458359 20462627 19502607 Thank you for your assistance. 05/23/2023
noted below by case number, pertaining to the drug solanezumab: 10309681, 9105404. Thank you for your assistance. 05/23/2023
noted below by case number, pertaining to the drug gantenerumab. Also please provide any cases not yet listed on the FAERS system
but under preparation for posting as of the date of this request. 19570648 05/23/2023
Copy of the disclosable portions of the 510(k) submission and related correspondence between FDA and applicant for K030674
(Modification to Axxess Spinal Cord Stimulation Lead).
1494, and 2023-3420.
7666, and 2022-7404.
3203, and 2022-553.
I'm requesting a copy of Food Contact Substance Notification (FCN) No. 1175, including all releasable FDA chemistry and toxicology
review memoranda and all correspondence. FCN 1175 clears the use of 5-sulfo-1,3-benzenedicarboxylic acid, monosodium salt (CAS
Reg. No. 6362-79-4)
FDA FAERS database for EYLEA (aflibercept). 05/30/2023
Please provide the following 1 inspection-related document in electronic PDF format: The EIR (in electronic format) for the Medical
Devices inspection of Alpha ProTech Inc. located in Salt Lake City, UT, US - Inspection ending 2023-05-11 (FEI 1721663). Please send
inspection of Incinta Fertility Center, LLC located in Torrance, CA, US - Inspection ending 2023-05-02 (FEI 3016710849). Please send
Devices inspection of Kamran Qureshi, M.D. located in Saint Louis, MO, US - Inspection ending 2023-04-28 (FEI 3025337001). Please
Devices inspection of Toby Orthopaedics, Inc. located in West Miami, FL, US - Inspection ending 2023-04-28 (FEI 3008747271). Please
Devices inspection of Aldeyra Therapeutics, Inc. located in Lexington, MA, US - Inspection ending 2023-04-28 (FEI 3013989915). Please
Drugs inspection of Priya U. Kumthekar, M.D. located in Chicago, IL, US - Inspection ending 2023-04-28 (FEI 3026091022). Please send
Devices inspection of Allison Medical, Inc. located in Littleton, CO, US - Inspection ending 2023-04-28 (FEI 1000138447). Please send
inspection of Lucile Salter Packard Children's Hospital Stanford Medicine Fertility and Reproductive Health located in Sunnyvale, CA, US -
Inspection ending 2023-04-27 (FEI 3003971418). Please send documents as email attachments. 05/31/2023
All communications regarding NDA 214755 from December 2020 to the present between the Office of Orphan Product Development
(OOPD) or any of its staff on the one hand, and the Office of Neuroscience (ON), the Division of Neurology 1 (DN1), or any of their
respective staff on the other.
All communications regarding NDA 214755 from December 2020 to the present between the Office of Orphan Product Development
(OOPD) or any of its staff on the one hand, and the Center for Devices and Radiological Health (CDRH), the Office of Product Evaluation
and Quality (OPEQ), the Office of Health Technology 1 (“OHT1”), the Division of Health Technology 1 C (DHT1C), or any of their
respective staff on the other.
2023-1473, 2023-1559, 2023-1585, 2023-1623, 2023-1688
2023-1748, 2023-1751, 2023-1761, 2023-1767, 2023-1776
AUROBINDO UNIT XIV or UNIT 14 4 observations
Form 483 from inspection of Aurobindo Pharma Limited's API Non antibiotic Manufacturing facility situated at Paravada Industrial Area,
Anakapalli District. Andhra Pradesh, India, between May 15 2023 to May 19 2023.
All records, reports, information, corrections, supplements, and correspondence relating to MAUDE Adverse Event Report Numbered
2031924-2014-00307 involving Trulign Toric Lenses.
All records, reports, information, corrections, supplements, and correspondence relating to MAUDE Adverse Event Report Numbered
2031924-2014-00288 involving Trulign Toric Lenses.
Sterilization of citizens through vaccines

How the food industry is poisoning Americans
etc 05/23/2023
Benzonatate capsules, 100mg & 200mg respectively under CREATES Act to buy both the RLD and RS that we need to support the drug
product reseach and development. Please help to provide the contact information including the company mailing address, the name of
the person as the point of contact and his or her title of both RLD holder Pfizer Inc(N011210,Tessalon Benzonatate Capsules, 100mg)
and RS holder Thepharmanetwork (A040627, Benzonatate Capsules, 200mg). 05/31/2023
Request for Curriculum Vitae under the Freedom of Information Act (FOIA) as per the guideline.
Any reports, protocols, data sets, and analyses directly related to the FDA50 analysis of 50 popular
commercial combustible cigarettes done by CTP and CDC in 2011 etc
I am requesting information on "Nature’s One’s (brand name). The official firm name is “Nat2 Inc”. The FEI number is3016994738 The
FDA database shows they had an inspection (inspection ID 1194101) on 12/2/2022 I am requesting all establishment inspection reports
(EIR), including related correspondence and any related Form 483s for the inspection (ID 1194101) detailed above for Nature’s One’s
manufacturing facility, located at 1675 James Parkway Heath, OH 43056.
Any and all records, correspondence, and meeting minutes related to Briumvi (ublituximab) and subcutaneous Kesimpta (ofatumumab)
indicated for treatment of MS (not the oncologic products with same generic names). Additionally requesting any correspondence or
reports related to exposure to Briumvi or Kesimpta in pregnant/lactating mothers and infants of treated mothers. Information will be
used for patient care decision-making. 05/24/2023
Any and all records, correspondence, and meeting minutes related to Bafiertam (monomethyl fumarate), Tecfidera (dimethyl fumarate),
and Vumerity (diroximel fumarate), pre- and post-marketing. 05/24/2023
The Investigational Product Accountability Logs (IPAL) for Clinical Trial C4591001, titled “Study to Describe the Safety, Tolerability,
Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals” conducted by Pfizer.
Information helpful to fulfilling the request: The ClinicalTrials.gov Identifier for this clinical trial is NCT04368728.
All consumer complaints received by the FDA concerning reported illnesses, injuries, or deaths among individuals who were implanted
with a device under Boston Scientific’s Lotus Edge Valve System (the “Lotus Edge”) between January 1, 2019 and the presentC
I would like to obtain the 90-day submission documentation for Mead Johnson's (Reckitt) Formula for Discharged Premature infants
currently named "NeuroPro Enfacare" powder or liquid formula for post discharge premature infants.
Dear sir, I have attached a document here titled: 21 CFR 172.809 (up to date as of 5/17/2023) Curdlan. In that document, there is a
reference titled: by Takeda Chemical Industries, Ltd., 12–10 Nihonbashi, 2–Chome, Chuo-ku, Tokyo, 103, Japan, 1996. Further, it also
refers to contact you to get this document. I highly appreciate if you can provide this reference document.
The following information for Clinical Trial C4591001, titled “Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of
RNA Vaccine Candidates Against COVID-19 in Healthy Individuals” conducted by Pfizer:
(1) Records showing all container numbers (i.e., vaccine vial number) for each injection received by each clinical trial subject.
ETC
I would like to obtain the 90-day submission documentation for Abbott's NeoSure Formula for Discharged Premature infants. I would
also like to obtain FDA correspondence to the submission that would have led to "no object." I understand in 1994 Abbott launched
"Similac NeoCare" but sometime later renamed it to "Similac NeoSure".
The DairiConcepts Manufacturing plant at 211 N. Central Ave in Allerton, IA was inspected by the FDA 5/16-6/30/2022 and a 483 was
issued June 30,2022 by the Principal Investigator Michael A. Feingold. DairiConcepts responded to FDA on July22 2022 and on October
19 2022. (The District address issuing the 483 was 8050 Marshall Drive in Lenexa, KS.) INSPECTION RECS
food additive petition (FAP 8M2205) filed by Armour and Co.
All records in the custody or control of the Office of Orphan Product Development (OOPD), the Office of Neuroscience (ON), the Division
of Neurology 1 (DN1), the Center for Devices and Radiological Health (CDRH), the Office of Product Evaluation and Quality (OPEQ), the
Office of Health Technology 1 (“OHT1”), the Division of Health Technology 1 C (DHT1C) reflecting consideration of whether NDA 214755
provides a major contribution to patient care or is otherwise clinically superior to other oxybate products.
FDA INSPECTION REPORT FROM 2022, FEI3003972256, NEVER RECEIVED COPY
FDA INSPECTION REPORT FROM 2022, Buffalo FEI: 3017876311
NEW INDIA SUPERMARKET - 483, FSVP
VINODS IMPORTS LLC - 483, FSVP
FIJI VANUA KAVA LLC - 483, FSVP
SONI'S SUPERMARKET - 483, FSVP
MANGALS MARKET LLC - 483, FSVP
FIJI SWEETS AND SNACKS - 483, FSVP
FIJIAN IMPORTS - 483, FSVP
PRAVESH KUMAR - 483, FSVP
MOHIT GOSAI 483, FSVP
MONTALVAN SALES INC - 483, FSVP
KUMAR IMPORTS 483, FSVP
DESI TASTE INC 483, FSVP
Copy of 483 for Intas Pharma Ltd, FDA identifier - 3003157498; DUNS: 725927649; address: Plot no 457/458 Matoda, Plot no. 191/218P
Chacharwadi, Sarkhej-Bavla Highway, Taluka-Sanand, Matoda, Ahmedabad, Gujarat 382210, India
I am an investment professional and this is a request under the Freedom of Information Act. Please provide the Form 483 issued to
Immunity Bio. This is FEI #3017966147, Immunity Bio, 9920 Jefferson Blvd, Culver City, CA. The Inspection Date was on February 10,
2023, per FDA website. 05/31/2023
entries that led to All Seasonings Ingredients, Inc.'s inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached
Waiver.
that led to Terova Inc's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver.
entries that led to HP Ingredients Corp.'s inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver.
entries that led to Bar & Cocoa's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver.
entries that led to Mclane Global, Inc.'s inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver.
Establishment Inspection Report for KP Pharmaceutical Technology FEI Number 3001802820,
inspection ID 1196557 from 2/3/2023
Records from FDA CVM for FDA requirements for regulating pet foods labeled as "prescription diets" 05/30/2023
Request for AEs, FDA Form 483 and filings for Prolacta Bioscience and Medolac Laboratories for exempt infant formulas.
Request for AEs, FDA Form 483 and filings for Mead Johnson for exempt infant formulas.
DairiConcepts in Allerton, IA EIR
A&S DISTRIBUTORS 483, FSVP
ISLAND PACIFIC HOLDINGS LLC 483, FSVP
ISLAND PACIFIC HOLDINGS LLC 483, FSVP 05/22/2023
SUMAN SINGH DBA FIJI MART 483, FSVP
TANOA KAVA 483, FSVP
SANTOS AGENCY 483, FSVP
BIJENDRA LALA 483, FSVP
ASAP SONS GROUP INC 483, FSVP
SASHI PRAKESH 483, FSVP
GOURMET INTERNATIONAL 483, FSVP
HATHI BRAND FOOD INC 483, FSVP
CVM 483s PREVIOUSLY RELEASED 05/23/2023
Haney, Inc. Cincinnati, Ohio United States End Dates of inspection: 18 Oct 2022 Project Area: Drug Quality Assurance FEI: 3007353165
charges exceed $ 200. 05/31/2023
Please provide copies of correspondence between Cameron Medical/Boston Scientific Corp and the FDA regarding the supplements on a
PMA P110042 device called the Emblem ICD A219.
Please provide the following 1 inspection-related document in electronic PDF format: The EIR (in electronic format) for the Medical
Devices inspection of Medtronic MiniMed, Inc. located in Northridge, CA, US - Inspection ending 2023-03-10 (FEI 3003166194). Please
Medical Devices inspection of Medtronic MiniMed, Inc. located in Northridge, CA, US - Inspection ending 2023-03-10 (FEI 3003166194).
Please provide the following 1 inspection-related document in electronic PDF format: The EIR (in electronic format) for the Human Drugs
inspection of The Procter & Gamble Manufacturing Company located in Greensboro, NC, US - Inspection ending 2023-03-10 (FEI
Requesting a copy of Food Contact Notification (FCN) No. 2265, including all releasable FDA chemistry and toxicology review
memoranda and all correspondence.
Human Drugs inspection of The Procter & Gamble Manufacturing Company located in Greensboro, NC, US - Inspection ending 2023-03-
10 (FEI 1017175). Please send documents as email attachments. 05/30/2023
inspection of Amy Lightner MD located in Cleveland, OH, US - Inspection ending 2023-04-26 (FEI 3026147808). Please send documents
as email attachments.
Drugs inspection of Tender Corporation located in Littleton, NH, US - Inspection ending 2023-04-26 (FEI 1250045). Please send
inspection of North Shore University Hospital Northwell Health located in Manhasset, NY, US - Inspection ending 2023-04-26 (FEI
Please provide inspection results for three 2023 inspections of Gary's Cheesecakes, and results of the inspections referenced in FDA
warning letter. (See attachment.)
Device inspection of LISI MEDICAL Remmele, Inc located in Big Lake, MN, US - Inspection ending 2023-04-27 (FEI 3009941480). Please
Device inspection of O&M HALYARD INC located in Alpharetta, GA, US - Inspection ending 2023-04-27 (FEI 3014421917). Please send
Device inspection of E-BEAM Services, Inc. located in Cranbury, NJ, US - Inspection ending 2023-04-27 (FEI 2245437). Please send
Device inspection of Lone Star Medical Products, Inc. located in Stafford, TX, US - Inspection ending 2023-04-27 (FEI 1627186). Please
Complete copies of K203714, and K222276
Device inspection of Ingen Orthopedics LLC located in Cranbury, NJ, US - Inspection ending 2023-05-03 (FEI 3005130928). Please send
Copy of the disclosable portions of the 510(k) for K201808, X-Tack Endoscopic HeliX Tracking System
Copy of the disclosable portions of the 510(k) for K091939, Thermedx Prodigy Fluid Management System, Models P1000, P2000.
A copy of any documents or memoranda concerning the Office of Orphan Products Development’s decision that Skytrofa
(lonapegsomatropin-tcgd) for injection, licensed on August 25, 2021 under BLA 761177, is or is not clinically superior to other
somatropin products for the same use.
Please provide Summary Basis of Approval of GLIPIZIDE TABLET ORAL 5MG and 10MG for the following mentioned Applicants: 1.
PFIZER INC (GLUCOTROL)-N017783 2. APOTEX INC - A075795 3. SUN PHARMACEUTICAL INDUSTRIES INC- A077820
Xtant Medical Holdings, Inc. recently acquired coflex® Interlaminar Technology, P110008. As such, Xtant Medical Holdings, Inc. is
requesting a complete copy of the PMA and it’s subsequent thirteen (13) Supplements.
Under the Freedom of Information Act, 5 U.S.C .§ 552, please provide copies of the disclosable portions of the Center for Tobacco
Products (CTP), Office of Science, reviewer’s summaries, TPLs, and any associated supporting CTP memoranda or reviewer guides for the
following STNs EX0002401, EX0002447, EX0001890-EX0001893, EX0001896-EX0001900, EX0002025, EX0002026, EX0002080,
EX0002092 & EX0001545.
Electronic listing (preferably csv format) of all RRAs conducted since 02/01/2023.
Under the Freedom of Information Act, 5 U.S.C .§ 552, please provide copies of the disclosable portions of the Center for Tobacco
Products (CTP), Office of Science, reviewer’s summaries, TPLs, and any associated supporting CTP memoranda or reviewer guides for the
following STNs (SE Exemption Granted determinations on 8/5/21): EX0001524, EX0001525, EX0001504.PD1, EX0001504.PD3 &
EX0001504.PD5
Electronic listing (preferably csv format) of all inspections conducted by FDA since February 1, 2023. The list should cover all FDA centers
and include each FDA inspection ID number, DUNS number and reason for inspection.
Subject: FAERS Individual Case Reports Suspect Drug: vigabatrin Case Number Source: FAERS Public Dashboard Case IDs: 10266165
10348924 10526044 10937196 13877025 14107672 14291924 14549591 15357965 19806594 20679683 21052747 05/30/2023
Under provisions of the Freedom of Information Act, I would like to request a list of all Foreign and Domestic Drug Inspections which
were conducted from January 1, 2000 to the present.
Please provide the disclosable portions of any correspondence, meeting agendas, meeting minutes or materials related to a cross-HHS,
inter-disciplinary effort led by Admiral Susan Orsega focused on cessation during the period 6/1/2022 to 5/16/2023. Our alternate
email address is foiafps@gmail.com.
Please provide a list of all foreign tobacco product manufacturers for which Remote Regulatory Assessments (RRAs) were conducted
during the dates March 2020 to 5/16/2023. Our alternate email address is foiafps@gmail.com.
Under the Freedom of Information Act, 5 U.S.C .§ 552, please provide PMTA submission dates for Velo products submitted by British
American Tobacco (BAT) between 1/1/22 – 12/31/22.
Medtronic OsteoCool RF Ablation System Full 510k (K182497)
Please provide a list of the "almost 400 publications" published in FY2022 as noted on slide 8 of Brian King's 3/1/2023 presentation to
the Society for Research on Nicotine and Tobacco titled, "Updates from FDA's Center for Tobacco Products."
Form FDA 483: Encore, Inc. Sarasota, FL End Dates of inspection: 20 February 2020 FDA District Office: Florida District District
We are requesting electronic copies of all communications between the Food and Drug Administration's Center for Devices and
Radiological Health: Office of Regulatory Programs and Penumbra, Inc. with respect to their Indigo Aspiration System - Lightning Flash
Device. We are requesting communications that occurred between January 1, 2023 and May 18, 2023. This 510(K) number associated
with the Penumbra device is K222358.
entries that led to the inclusion of the following companies in this list for the last 2 years (April 1, 2021 - April 30, 2023).
that led to Henan International, Inc.'s inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver.
that led to Minuti Coffee LLC's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver.
On the publicly available FDA site: https://www.fda.gov/media/119312/download FDA provides a list of companies participating in the
that led to Supermercados Econo Inc's inclusion in this list for the last 2 years (April 1 2021- April 30 - 2023). See attached waiver.
that led to La Parcela Produce LLC's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023).
Freedom of Information Act Request – Documents Pertaining to

MDO for Mothers Milk WTA PMTA submissions for more than 250
flavored and tobacco-flavored e-liquids
1. Records relating to Florida's SIP proposal.

2. Records relating to Canadian drug importation programs, including SIP proposals, for the
following states: Colorado, New Mexico, New Hampshire, Vermont, and Maine. etc
As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Gojo
Industries Wooster, Ohio United States End Dates of inspection: 05 Aug 2022 Project Area: Drug Quality Assurance FEI: 3011493299
charges exceed $ 200. 05/31/2023
Cyalume Specialty Products Inc. Bound Brook, New Jersey United States End Dates of inspection: 03 Oct 2022 Project Area: Drug Quality
Assurance FEI: 2243955 Classification: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request, however
please contact me if the charges exceed $ 200. 05/30/2023
Century Pharmaceuticals, Inc. Indianapolis, Indiana United States End Dates of inspection: 25 Oct 2022 Project Area: Compliance:
Devices FEI: 1819174 Classification: VAI 05/30/2023
Form 483 (including all accompanying documentation regarding inspection request), and EIRs for January 1, 2023- May 18, 2023 at the
following Eli Lily facility located in Belgium (Rentschler's Baden-Wurttemberg, Germany)
I request a copy of Form 483 (including all accompanying documentation regarding inspection request), and EIRs for January 1, 2021 to
May 18, 2023 at the following Catalent Pharma facilities located at Harmans/BWI, Maryland Facility: 7555 Harmans Road, Harmans, MD
21077
May 18, 2023 at the following Catalent Pharma facilities located in Brussels, Belgium at Rue Font St Landry, 10 Parc Mercator B-1120
Neder Over Hembeek, Belgium
May 18, 2023 at the following Catalent Pharma facilities located at Bloomington, Indiana Facility: 1300 S. Patterson Dr. Bloomington, IN
47403.
Form 483 (including all accompanying documentation regarding inspection request), and EIRs for January 1, 2023- May 18, 2023 at the
following Eli Lily facility located in Indianapolis, IN: Lilly USA 1500 South Harding Street Indianapolis, IN 46221
Documents sufficient to disclose which applicants have been certified as small businesses in the past 5 years and the time periods for
which those certifications were in effect. To be more specific, the documents I am seeking relate to the "Small Business Determination
Program" for medical devices as described here: https://www.fda.gov/medical-devices/premarket-submissions/reduced-medical-
device-user-fees-small-business-determination-sbd-program Thank you for your help.
RECS RE BLACK MOLD 05/23/2023

ORIGINAL DRUG TRIAL DATA NALOXONE IV, ETC
As we are the manufacturer and submitter of 510(k) No. K180578, we would like the entire record. We have misplaced the submission
and would like to have it on file at our site.
Please provide Summary Basis of Approval of SODIUM PHENYLBUTYRATE (OLPRUVA) FOR ORAL SUSPENSION
2GM/PACKET,3GM/PACKET,4GM/PACKET,5GM/PACKET,6GM/PACKET and 6.67GM/PACKET for the Applicant ACER THERAPEUTICS INC-
N214860 05/24/2023
FDA Form 483 issued as a result of inspection ID: 1121818 with end date 1/31/2020 for the following company: Sharp Mint Limited C -
03 Sma Cooperative Industrial Estate, G T Karnal Road Delhi, Delhi 110033 India 05/31/2023
Requesting the approved labeling for ANDA 216324 for Cupric Sulfate (to include the package insert and carton/container labeling) 05/31/2023
Please provide Summary Basis of Approval of RISPERIDONE TABLET, ORALLY DISINTEGRATING ORAL 0.5MG,1MG,2MG for the Applicant
JUBILANT GENERICS LTD-A090839 05/24/2023
Device inspection of Hearing Lab Technology, LLC located in Bristol, PA, US - Inspection ending 2023-04-20 (FEI 2523532). Please send
Drugs inspection of PETNET SOLUTIONS, INC. located in Knoxville, TN, US - Inspection ending 2023-04-21 (FEI 3008789905). Please send
Drugs inspection of Copperhead Chemical Company Inc. located in Tamaqua, PA, US - Inspection ending 2023-04-24 (FEI 2517101).
Device inspection of Neurotris, Inc. dba A1 Engineering located in Irvine, CA, US - Inspection ending 2023-04-25 (FEI 3008069988).
FDA approval routing sheets 05/31/2023
REMOTE REGULATORY ASSESSMENT LIST
Request for dataset under the Freedom of Information Act (FOIA) for FDA registration.
Any and all documents regarding monitoring the Sterigenics International Inc facility located at 84 Park Road, Queensbury, NY for
compliance with 40 CFR Part 63 Subpoart O – Ethylene Oxide Emissions Standards for Sterilizations Facilities from 1993 to the present
that led to Morton Salt Inc.'s inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver.
that led to XF Enterprises, Inc.'s inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver.
that led to Accardi Foods' inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver.
that led to Edward & Sons Trading Co., Inc.'s inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver.
that led to Select Produce LLC's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver.
that led to Loumidis Foods, Inc.'s inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver.
that led to Ikal LLC's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver.
that led to Big V Feeds' inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver.
Hi, I am an investment professional and this is a request under the Freedom of Information Act. Please provide Form 483s and Warning
Letters issued to Integra Lifesciences Corporation and/or their subsidiary TEI Biosciences at FEI #3004170064, 7 Elkins Street, Boston,
MA, 02127. Please provide for January 1, 2023, to May 23, 2023.
We are seeking EIR documents from a closed Brooks Life Sciences location in El Segundo CA: The first EIR needed is Inspection ID #
939444, Product Type: Biologics Classification: NAI Date: 08/21/2015 The second EIR needed is Inspection ID # 996824, Product Type:
Biologics Classification: NAI Date: 11/29/2016
Mirtazapine Tablets USP, 7.5 mg - Suitability Petition # 02P-0249 1) Original Filed Suitability Petition 2) Any supplemental information
submitted by petitioner post original submission 3) Approved Suitability Petition
All records related to the recall of the Aziyo FiberCel Fiber Bone Viable Bone Matrix product, Donor Lot #NMDS210011, initiated on or
about June 2, 2021 including all investigations performed and the outcome of same, to include all inspections, notifications, statements,
correspondence, notes, memos, e-mails and reports.
Pursuant to the Freedom of Information Act, 5 U.S.C. § 552, and FDA's implementing regulations, 21 C.F.R. Part 20, I am requesting
a hard (paper) copy and digital (pdf) copy of the following documents: • All files, documents, and communications related to the
following three FDA Complaints: o CC 179845 Micro Ingredients Organic Ginkgo Biloba Powder o ETC
I am an investment professional for an asset management firm. I am writing to ask for copies of all correspondence between the FDA
and UCB Pharma between 01 Jan 2023 to 24 May 2023 relating to the Biologics License Application resubmission for bimekizumab,
including, but not limited to, any observations from inspections conducted at the Braine-l'Alleud facility during 2023.
I am requesting the information submitted to you under CAERS report ID 2022-

CFS-007637, created 21MAY22 regarding “PROLACT PLUS 4H2MF HUMAN MILK". We are the manufacturer of aforementioned product.
Copy of the disclosable NGE and RAR for the inspection of X-NAV Technologies, LLC, Lansdale, MI , end date 06-02-2017. FEI#
Copy of the disclosable NGE and RAR for the inspection of Medtronic Advanced Energy, LLC, Portsmouth, NH , end date 05-25-2017. FEI#
Copy of the disclosable NGE and RAR for the inspection of Allesee Orthodontic Appliances, Sturtevant, WI , end date 05-24-2017. FEI#
Copy of the disclosable NGE and RAR for the inspection of Ethicon, Inc., Cornelia, GA , end date 05-12-2017. FEI# 1049223. This
Copy of the disclosable NGE and RAR for the inspection of Metrex Research, LLC., Romulus, MI, end date 05-05-2017. FEI# 1000117344.
This inspection pertains to medical devices.
Drugs inspection of Spectrum Laboratory Products Inc. dba Spectrum Chemical Mfg. Corp. located in New Brunswick, NJ, US - Inspection
ending 2023-03-24 (FEI 2246824). Please send documents as email attachments.
Biologics inspection of Berkshire Sterile Manufacturing, Inc. located in Lee, MA, US - Inspection ending 2023-01-20 (FEI 3012144557).
Please provide the following 1 inspection-related document in electronic PDF format: The EIR (in electronic format) for the Biologics
inspection of Berkshire Sterile Manufacturing, Inc. located in Lee, MA, US - Inspection ending 2023-01-20 (FEI 3012144557). Please send
Drugs inspection of PETNET SOLUTIONS, INC. located in Hayward, CA, US - Inspection ending 2023-04-24 (FEI 3013979112). Please send
Device inspection of Alcon Research, LLC located in Irvine, CA, US - Inspection ending 2023-04-25 (FEI 1000125771). Please send
Device inspection of Teledyne Analytical Instruments located in City of Industry, CA, US - Inspection ending 2023-04-25 (FEI 2026424).
that led to A True Move, LLC.'s inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver.
that led to Martinez Produce & Seafood, Inc.'s inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached
Waiver.
Requesting an unreacted copy of the EIR issued for the FDA Inspection of PDA Laboratories, 6 N Corporate Drive, Riverdale, NJ 07457
Inspection conducted in November 2022.
I am requesting the FDA "summary basis of review" document for Ayvakit's sNDA approval for 25mg for indolent systemic mastocytosis
on May 22 2023. On the drugs@FDA website, there is only the summary basis of review for the original approvals for GIST January 9
2020 and advanced systemic mastocytosis June 16 2021 but nothing for the indolent systemic mastocytosis approval on May 22 2023.
All email records for FDA CVM employee Tim Schell containing the key search term: AAFCO 01.01.2021-04.30.2022
2022-1970 05/31/2023
Any and all records related to PETA’s March 29, 2023 request to investigate Cool Zoo, dba Mister Crabs’ (addressed to Ms. Kerosky).
“Records” includes, but is not limited to, inspection reports, citations, agency final decisions of action/inaction, permits/permit
applications, photos, videos, and email or other correspondence.
1. Records and communications of the below-listed U.S. Food and Drug Administration (FDA) persons, including emails, email chains,
email attachments, text messages, voice recordings, correspondence, letters, spreadsheets, logs, briefings, meeting minutes, calendar
invites, calendar meetings, memoranda, or reports regarding Abrysvo, a respiratory syncytial virus vaccine (RSV) recently recommended
by the Vaccines and Related Biological Products Advisory Committee.
1. Records and communications of the below-listed U.S. Food and Drug Administration (FDA) persons, including emails, email chains,
email attachments, text messages, voice recordings, correspondence, letters, spreadsheets, logs, briefings, meeting minutes, calendar
invites, calendar meetings, memoranda, or reports regarding Arexvy, a respiratory syncytial virus vaccine (RSV) vaccine candidate in
pregnant women.
Recs re EUAs EUA220333 and EUA220490; The materials may include but not be limited to emails from the inboxes of FDA personnel
including Toby Lowe, Tim Stenzel, or Jeff Shuren to personnel at Lucira including David McGrath and Felicia Hosey.
Public Records Request, Salmonella Newport Outbreak in Summer 2020

I am an investment professional at an asset management firm and would like to request all Form 483s issued by the FDA inspector John
L. Zaccone in the last 5 years 05/24/2023
I am an investment professional at an asset management firm and would like to request all Form 483s issued by the FDA inspector Kent
A. Conforti in the last 5 years 05/24/2023
I am an investment professional at an asset management firm and would like to request the Summary EIR for the inspection occurring
from 03/20/2023 – 03/31/2023 at SpringWorks Therapeutics, Inc. located at 5310 S. Alston Ave, Suite 230, Durham, NC 27713. The FEI
number is 3026006210
I am an investment professional at an asset management firm and would like to request all Form 483s issued by the FDA inspector
Tyanna N. Hadley in the last 5 years 05/24/2023
All Establishment Inspection Reports (EIRs) and supporting documentation such as 483s, 484s, wanting letters, etc. for Mushroom
Harvest, Inc. for inspections conducted by the FDA and/or contracted to the state. Mushroom Harvest is currently owned by George
Vaughan and located in Sequim, WA, but was previously located in Athens, Ohio.
Internal FDA Documents and Communications re: Korlym’s NDA etc

Complete electronic copy of K112595, Coflex-F, cleared 02/13/2012. 05/25/2023
Complete electronic copy of K153302, Coflex-IF, cleared 09/08/2016.
Complete electronic copy of K201704, Cofix System, cleared 08/04/2020.
On the FDA website there is a list called: "Submissions on post consumer recycled plastics for food contact articles". I would like to
receive the complete submission and FDA response letters for the following Recycle/ID numbers: 186, 190, 199, 231, 234 and 250.
2023-2944, 2023-2945, 2023-2946
Form FDA 483 Inspection Records DRE Medical Group, INC dba Avante Health Solutions 2601 Stanley Gault Pkwy, Ste 101 Louisville, KY
40223
Kindly provide me with the inspection dates, classification awarded and the date when classification was awarded to various facilities
inspected by the USFDA for Drug Quality Assurance over the last 6 years.
FDA Review notes related to 510(k) K222095.
Under the Freedom of Information Act, 5 U.S.C. subsection 552, I am requesting access to a list of all drugs that were or are undergoing
US clinical trials that were placed on a partial or full clinical hold by the FDA between 01/01/2013 and 05/01/2023. 05/31/2023
I am seeking an official copy of the FDA approval package for NDA No. 022410 (Suboxone Film) which was approved on August 30, 2010.
MedWatch Forms (FDA Form 3500A) or Case Narrative for the following FAERS Cases: Case ID: 21652798 21500256 21779763 21643887
21959078 20366430 21916919 21892206 20364232 19260138 21890887
EIR for FDA inspection (ID: 1121818 End date: 1/31/2020) for the following company: Sharp Mint Limited C - 03 Sma Cooperative
Industrial Estate, G T Karnal Road Delhi, Delhi 110033 India FEI: 3004293539
2023-2756, 2023-2757, 2023-3339, 2023-2842, 2023-3169
Study KEYNOTE-010 (NCT01905657) https://clinicaltrials.gov/ct2/show/NCT01905657, supporting market approval of Keytruda in
previously treatment NSCLC patients.
Complete FDA response for File Numbers 2018-10341, 2022-7554, and 2022-8469.
DRE MEDICAL GROUP 483 January 1, 2008 to December 31, 2019.
To Whom It May Concern: I am seeking information related to the approval of FDA 510K Clearance: K230637.
In study KEYNOTE-021 (https://clinicaltrials.gov/ct2/show/NCT02039674, to support Keytruda market approval in first line treatment of
metastatic NSCLC). A: Please share the patient level data to support table 17 in Summary Basis of Approval page 34:
(https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/125514Orig1s014.pdf).
Copy of the complete FDA response for the following File Numbers: 2022-5315, 2023-307, 2023-309, 2022-8780, 2022-8015.
Office of Generic Drugs Approval letters, both tentative and final, for Abbreviated New Drug Application # 216019, Pharmadax, Inc.'s
generic nifedipine extended release product. 05/30/2023
On behalf of Lupin Pharmaceuticals Inc. I would like to request the TENTATIVE APPROVAL letter for the NDA 214755 (AVADEL CNS) 05/31/2023
I am an investment professional at an asset management firm and would like to request a list of all inspections conducted by the FDA
inspector Tyanna N. Hadley in the last 5 years.
inspector Kent A. Conforti in the last 5 years
inspector John L. Zaccone in the last 5 years
Requesting the label (carton and vial) for NDA 019350 for Cupric Sulfate. Request the latest approved version of the carton and vial
labeling for the product, originally approved on May 5, 1987 and the last supplement approved on June 9, 1992 05/30/2023
Requesting a copy of Food Contact Notification (FCN) No. 308, including all releasable FDA chemistry and toxicology review memoranda
and correspondence.
I am seeking a copy of the response to an FDA Warning Letter to Gary’s Cheesecake & Fine Desserts. The response was sent on May 10,
2023.
Requesting access to all administrative file information pertaining to INAD 011-822 (requested May 8, 2009) and relating to the subject
“improved reproductive performance in beef cattle, non-lactating dairy cattle. Also include all correspondence as a result of the types of
submissions, i.e. CVM meeting minutes, etc.
In Accordance with the Freedom of Information Act request please provide records relating to removal of ocular risk information from
Section 6.3 of Avastin (bevacizumab) label.
RECS RE Eric C. Donny et al., Randomized Trial of Reduced-Nico¿ne Standards for Cigare¿es, 373 New
England Journal of Medicine 1340–1349 (2015), DOI: 10.1056/NEJMsa1502403 ETC
Copy of 510(k) # K221537, Smylio Inc. Nightwear Aligners
Please see attached information for this 1979 petitions request.
Form 483 Inspection Finding Report Harvest Valley Bakery, Inc 348 Civic Rd, La Salle Il 61301 Auditor Justin Hayes Inspection date:
1/18/2023
483 observations at UCB Pharma manufacturing plant, Braine-l’Alleud 05/31/2023
Hello -- I request all responsive records issued in response to FOIA #2016-5906, which asked for all "IVF, ASSISTED REPRODUCCTION
CLINICS HANDLING HUMAN REPRODUCTIVE TISSUES - WARNING LETTERS, INSPECTION RECS, ETC 01/01/2010 - 07/06/2016". 05/26/2023
Division of Neurology Products, Sodium Oxybate Consultation Request (Nov. 24, 2017), including any exhibits, attachments, appendices
or other materials attached or appended to that document; and • FDA, Review of Amended Request for Orphan Drug Designation for
sodium oxybate, DRU-2016-5302 (Dec. 21, 2017), including any exhibits, attachments, etc
We would like to obtain a copy of the Atteris No-sting Skin Protectant 510(k) (K160684) 05/26/2023
Good day, We would please like the following 510k submissions: 1. K190651 2. K15041 3. K051509 4. K934261 (this request was
already processed by another organization in 2015) Thank You
K151830, K103595, K071178, K062672, K981575 this request has already been made by the Harvard Wyss Institute for Biologically
Inspired Engineering on Recd 02/05/2019 with control number 2019-773 05/26/2023
The FDA inspection 483s. The inspected facility name is Par Sterile Products LLC (FEI number:1818977; DUNs number: 808402890),
located at 870 Parkdale Rd., Rochester, Michigan (MI) 48307, United States (USA).
K173450 510(k) Submittal requested from Nemoto Kyorindo Co., Ltd. PRESS DUO elite, PRESS DUO elite AG This has been previously
requested with control # 2018-1575 05/26/2023
Freedom of Information Act (FOIA) request relating to the e-liquid flavor wheel classification.
I would like to request copies of any contract, agreement or endorsement agreements between the Food and Drug Administration and
any of the following individuals and entities: The University of Georgia, The University of Georgia Athletics Association (UGAAA),
student-athletes at UGA, or any staff member of UGA or the UGAAA.
presentations and memos related to cannabis, cannabinoid, and cannabidiol between January 1, 2022 and May 25 2023.
Human Adverse Drug MedWatch Reports for the following Case IDs: 10733203 10786890 10836059 10931598 10951822 10968778
10968779 10989130 11044075 15161034 18299452 18554081
Please provide Summary Basis of Approval of BETAMETHASONE DIPROPIONATE and CLOTRIMAZOLE CREAM TOPICAL EQ 0.05% BASE;
1% for the Applicant TARO PHARMACEUTICALS USA INC-A075673 05/26/2023
To the extent that Fate Therapeutics, Inc. (“Fate”) submitted any IND application to the FDA between January 1, 2021 and January 31,
2023 for Fate’s CAR NK cell product candidates designated as FT555 (for treatment of multiple myeloma) and FT562 (for treatment of B-
cell lymphoma), we respectfully request that the FDA produce copies of: (a) correspondence between Fate and the FDA regarding the
IND applications etc
483s issued for the period April 1st 2023 – May 25th 2023 for the below two facilities?
1. UCB Pharma S.A., site of Braine-L’Alleud. Chemin du Foriest. B- 1420 Braine-L’alleud
2. UCB Pharma GmbH,. Alfred-Nobel-Strasse 10. 40789 Monheim am Rhein
05/31/2023
483s issued for the period April 1st 2023 – May 25th 2023
1. Rentschler Biopharma SE, Erwin-Rentschler Str. 21, 88471 Laupheim, Germany

2. Rentschler Biopharma Inc., 27 Maple Street, Milford MA, 01757 USA
3. Rentschler ATMP Ltd, Sycamore House, 2 Gunnels Wood Road, Stevenage, SG1 2BP UK
Thank you.
K202623, Novapak Nasal Sinus Packing and Stent

FOIA request for Premarket Tobacco Product Application (PMTA) Refuse to File (RTF) decisions.
Copy of the PMA for P160053, Magtrace and Sentimag Magnetic Localization System, by Endomagnetics.
Evaluation (Review) Report for our approved ANDA 209397, Fluvastatin Sodium Extended-Release Tablets 80 mg. The ANDA application
was submitted on March 28, 2017, and approved by FDA on April 26, 2021. Australia TGA is asking for the evaluation/review report for
our ANDA application.
K070715, Nasopore® Ear
Original NDA # N020121 for Flonase Rx
K052099, Nasopore® Nasal dressing
inspection of Dental Prosthetic Services Inc [Cedar Rapids / United States of America], 1900 51ST ST NE, CEDAR RAPIDS, IA, 52402-2459,
UNITED STATES - Inspection, 2023-04-20 (3000171384). Please send documents as email attachments.
inspection of Ecotec Manufacturing, Inc., 312 SW 7TH AVE, OKEECHOBEE, FL, 34974-4279, UNITED STATES - Inspection, 2023-04-20
inspection of Playtex Manufacturing Inc, Inc., 1190 U.S. HIGHWAY 1 NORTH, ORMOND BEACH, FLORIDA (FL) 32174, UNITED STATES
(USA) - Inspection, 2023-04-19 (1027735). Please send documents as email attachments. 05/31/2023
inspection of IntriCon Corp, 4400 MCMENEMY ST, VADNAIS HEIGHTS, MN, 55127-6005, UNITED STATES - Inspection, 2023-04-17
inspection of Tensentric, LLC, 474 S TAYLOR AVE STE C, LOUISVILLE, CO, 80027-9748, UNITED STATES - Inspection, 2023-04-14
inspection of Netech Corp., 110 TOLEDO ST, FARMINGDALE, NY, 11735-6623, UNITED STATES - Inspection, 2023-04-14 (1000522032).
inspection of Nortech Systems, Inc, 925 6TH AVE NE, MILACA, MN, 56353-3773, UNITED STATES - Inspection, 2023-04-14 (2183613).
inspection of Sanitor Corporation, 8400 CERRITOS AVE, STANTON, CALIFORNIA (CA) 90680, UNITED STATES (USA) - Inspection, 2023-04-
inspection of Artegraft, Inc., 206 N CENTER DR, NORTH BRUNSWICK, NJ, 08902-4246, UNITED STATES - Inspection, 2023-04-13
inspection of BBS Enterprises, DBA Complexus Medical, 55980 RUSSELL INDUSTRIAL PKWY, MISHAWAKA, IN, 46545-7545, UNITED
STATES - Inspection, 2023-04-12 (3009887475). Please send documents as email attachments.
FOIA request for documents relating to FCN No. 970.
FOIA request letter relating to Pastel Cartel PMTAs.
I would like to make an open records request for a list of IVF/fertility facilities broken down by year that received FDA form 483s or a
warning letter from January 1, 2020 to the present.
Dear Open Records Custodian: Under the Maryland Public Information Act Title 4 and on behalf of CNBC, I am requesting an
opportunity to inspect or obtain copies of all correspondence, including letters and emails, between the FDA and the brain-computer
interface company Neuralink regarding its first in-human study. Please share said correspondence in an email format.
Documents relating to the design of the clinical trial for the Neuralink "Link" device. Specifically: the size of the sample group what
experiments will be conducted, what controls will be used (i.e. placebo device) what data will be collected, and how this data will be
analyzed.
All applications and supporting documents for human subject trials from Neuralink and all FDA responses including rejections and
approvals and any other supporting documents.
I'm seekign for data related to food alerts, withdrawalS and food recalls in US. 05/30/2023
I am an investment professional at an asset management firm and would like to request all form 483s issued since 2018 to present for
the TEI Biosciences, Inc. facility located at 7 Elkins Street, Boston, MA, 02127. The FEI Number is 3004170064.
Robert M. Califf M.D. Oath of office and photocopy of your Public Official Surety 05/30/2023
FOIA request for FDA’s unredacted review memoranda and correspondence related to Pastel Cartel LLC’s Premarket Tobacco Product
Application (PMTA); FDA Submission Tracking Number (STN): PM0005906.PD1
Harvest Valley Bakery, Inc EIR report from GMP inspection on January 18, 2023
FDA CDER Dermatologic and Ophthalmic Drugs Advisory Committee, Thurs 11/4/99, Gaithersburg Maryland, open session NDA 21-022
Loprox (ciclopirox Nail Lacquer) for the treatment of onychomycosis requesting transcript and associated slides 05/30/2023
Copy of 510k submission document for K211868 (Device Name: Myah)
I am an investment professional for an asset management firm and would like to request the Summary EIR provided for the inspection
occurring on 04/22/2023 at Sanofi Pasteur Inc., located at 1 Discovery Drive, Swiftwater, Pennsylvania (PA) 18370, United States (USA).
The FEI Number is 2518760
Copy of the disclosable portions of the complete FDA responses for the following File Numbers: 2022-2984; 2022-3809; 2022-4504;
2022-4546; and 2022-5701.
Copy of the disclosable portions of the complete FDA responses for the following File Numbers: 2022-5961; 2022-6216; 2022-6584;
2022-6964; and 2022-7041.
Please send the summary and submission for 510(k) Number K842493. We are particularly interested in seeing the testing protocols
used to establish equivalence to other devices. More detail is below. Device Name AGEE EXTERNAL FIXATOR Regulation Number
888.3040 Classification Product Code JEC Date Received06/26/1984 Decision Date 02/13/1985
I am an investment professional for an asset management firm and would like to request the Form 483 provided for the inspection
occurring on 04/22/2023 at Sanofi Pasteur Inc., located at 1 Discovery Drive, Swiftwater, Pennsylvania (PA) 18370, United States (USA).
The FEI Number is 2518760 05/31/2023
K211855 Ion Facet Screw System 510k premarket notification full submission
2023-1794, 2023-1927, 2023-1993, 2023-2134, 2023-2193.
I am seeking inspection records pertaining to TEI Bioscience's Boston, MA facility. The records may also be under Integra LifeSciences,
which acquired TEI. I am looking for all Form 483s and other inspection records. I am also seeking records of communication with the
FDA regarding a May 2023 recall of all product shipped from the facility since 2018.
We respectfully request all entry-line records that contain any of the following data points in reference to any entry’s FSVP Importer,
Importer of Record, or Consignee; for entry-lines with submission or arrival dates from May 01 to May 31, 2023: 1) DUNS Number /
Unique Facility Identifier (UFI) of 080801169 2) Name of United Safety Agents, United Safety, or variations of the same ETC
Janssen Ortho LLC Gurabo, Puerto Rico United States End Dates of inspection: 28 Mar 2023 Project Area: Drug Quality Assurance FEI:
3002942061 Classification: VAI
Kearney, Susan L., M.D., Clinical Investigator Minneapolis, Minnesota United States End Dates of inspection: 10 May 2022 Project Area:
Bioresearch Monitoring FEI: 3012808543 Classification: VAI 05/31/2023
2023-2201, 2023-2242, 2023-2252, 2023-2419, 2022-4430.
Brenda L Reihing, Linda J Cruz, Merril E Racke, Robert Sharpnack, ETC
As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Osteolife
Biomedical I LLC 1951 NW 7th Avenue Sanibel Suite Miami, FL 33136 United States End Dates of inspection: 04 Feb 2022 FEI
3014623896 Project Area: Human Cellular, Tissue, and Gene Therapies MARCS-CMS 626889 05/31/2023
As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Smitha C.
Reddy, M.D./ACRC Studies, LLC 15725 Pomerado Road, Suite 103 Poway, CA 92064-2058 United States End Dates of inspection: 20 Aug
2021 FDA Ref.: 22-HFD-45-05-01 MARCS-CMS 634702 05/31/2023
As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Medtronic,
Inc. 710 Medtronic Parkway Minneapolis, MN 55432 United States End Dates of inspection: 07 Jul 2021 MARCS-CMS 617539
As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Mylan
Laboratories Limited – Unit 7 1000 Mylan Boulevard Canonsburg, PA 15317 United States End Dates of inspection: 28 Feb 2020 FEI
3003227156 MARCS-CMS 607508
As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Cryos
International USA LLC 2200 N. Alafaya Trail, Suite 550 Orlando, FL 32826 United States End Dates of inspection: 08 Mar 2022 FEI
3011402904 MARCS-CMS 639696 05/31/2023
As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Cryos
International USA LLC 2200 N. Alafaya Trail, Suite 550 Orlando, FL 32826 United States End Dates of inspection: 08 Mar 2022 FEI
3011402904 MARCS-CMS 639696 05/31/2023
As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Trilogy
Laboratories, LLC 10060 Amberwood Rd., Suite 1 Fort Myers, FL 33913 United States End Dates of inspection: 27 Aug 2019 FEI
3012491944 MARCS-CMS 595087 05/31/2023
As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Vitti Labs, LLC
834 W. Kansas St., Suite C Liberty, MO 64068 United States End Dates of inspection: 20 Dec 2021 FEI 3015365441 MARCS-CMS 627699 05/31/2023
As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: "Daniel C.
Tarquinio, D.O./Center for Rare Neurological Diseases 5600 Oakbrook Parkway, Building 100, Suite 120 Norcross, GA 30093-1843 United
States End Dates of inspection: 05 Nov 2021 FDA Ref. No.: 22-HFD-45-03-05 MARCS-CMS 630976 05/31/2023
Recs Eastern Cosmetic Surgical Institute investigation etc between May 1, 2019 and May 30, 2020
We write to request the documents produced to Quinn Emanual Urquhart & Sullivan LLP under FOIA control numbers: 2020-5221;
2021-8293; 2021-8294; 2021-8295; 2021-8296; 2021-8829; 2021-8830; 2021-8831; 2021-8832; 2022-27; 2022-28; 2022-29; 2022-30;
2022-630.
We are requesting UN-redacted copies of our three 510K approvals. Here are the 510K numbers: K103470 K142577 K152618 We are
requesting to receive theses documents as soon as possible. We have also included an Attestation Approval Request letter signed and
stamped by the parent company. Thank you
510(k) submission files for CellFX® System, K203299, cleared 02-Feb-2020
510(k) number K220634 for the NC TREK NEO Coronary Dilatation Catheter.
Requesting all records associated with 510(k) K981797, "B-D Pen Ultra 1.5 ml and 3.0 ml Versions". 05/31/2023
Requesting all records associated with 510(k) K980755, "B-D 3 ml Pen".
Requesting all records associated with 510(k) K951919, "B-D PEN ULTRA". 05/31/2023
Hello -- I'm a reporter for The Washington Post, and under public records laws I am requesting an electronic copy of the FDA Form 483s
issued to the Center for Human Reproduction, a fertility clinic, on the following dates: Feb. 3, 2012, April 7, 2014, and Feb. 23, 2016. The
Center for Human Reproduction is located in New York, New York.
Any and all documentation and/or correspondence related to Mosie LLC (also commonly referred to as Mosie Baby) or its Mosie Baby
Kit , including any trade complaints, inquiries, or other enforcement or investigatory documents.
I am an investment professional and this is a request under the Freedom of Information Act. Please provide all Form 483 issued to
BioMarin Pharmaceutical, Inc. at FEI # 3004079983, 46 Galli Drive, Novato, CA 94949. Please provide for December 1, 2022, to May 29,
2023.
Copies of the NOL dated December 13, 2023 issued to Circulus Holding for its low density polyethylene (LDPE) post-consumer recycled
(PCR) polymer plastic and the company's initial submission in support of the NOL request.
that led to Comercializadora del Midwest's inclusion in this list for the last 2 years (April 1, 2021 - April 30, 2023). See attached Waiver.
Please provide any and all records of laboratory test results or reports from the Ciguatera Fish Poisoning of Svetlana Quaranto (DOB:
12/12/1966). The Ciguatera Fish was consumed on August 30, 2020. The Ciguatera Fish samples were delivered for testing the week of
September 7, 2020.
I am an investment professional at an asset management firm and would like to request any form 483s issued from 02/01/2023 to
present for any facility with “Asymchem” in the firm name. If there are no 483s issued, please confirm if any facilities (with “Asymchem”
in the firm name) have been inspected
Copy of the disclosable NGE and RAR for the inspection of Kerr Corporation, Romulus, MI , end date 05-03-2017. FEI# 1815757. This
Copy of the disclosable NGE and RAR for the inspection of Lumedx, Bellevue, WA, end date 04-20-2017. FEI# 3008012314. This
Copy of the disclosable NGE and RAR for the inspection of Kensey Nash Corp. dba DSM Biomedical, Exton, PA, end date 04-13-2017. FEI#
Copy of the disclosable NGE and RAR for the inspection of Ellman International, Inc., Hicksville, NY , end date 03-10-2017. FEI# 2428235.
This inspection pertains to medical devices.
All documents, communications and/or records related in any way, to FDA's 2023 Inspection of Central Admixture Pharmacy Services,
Inc., located in Allentown, PA.
Copies of the No Objection Letter (NOL) dated March 31, 2023 sent to St. Joseph Plastics for its Polypropylene (PP) post-consumer
recycled (PCR) plastic and the company's scientific submission provided to FDA in support of the Agency's granting of the NOL.
Copies of the No Objection Letter (NOL) dated December 23, 2022 sent to Merlin Plastics Supply, Inc. for its Polypropylene (PP) post-
consumer recycled (PCR) plastic and the company's earlier scientific submission provided to FDA in support of the Agency's granting of
the NOL.
All of the following records (to include documents in any form and communications) with regard to black turmeric and curcuma casia
and c. casia (to include the herb as well as any extracts or substances derived therefrom): 1) GRAS notifications, responses and follow-
ups; 2) new dietary ingredient notifications, responses and follow-ups; 3 ETC
CORR BETWEEN FDA AND ALZHEIMER'S LIGHT, RUBYLUX LLC, GAMMA, ETC

FDA FOIA Log - May 2023

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FDA FOIA Log - May 2023

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Control # Recd Date From

2023-3468 05/01/2023 FDAZILLA

2023-3469 05/01/2023 Harrington Films

2023-3474 05/01/2023 FOI Services, Inc.

2023-3475 05/01/2023 ON POINT INVESTIGATIONS

2023-3476 05/01/2023 Merck&Co., Inc

2023-3478 05/01/2023 Styrax Cap

2023-3479 05/01/2023 Kulkarni, Nivedita T

2023-3480 05/01/2023 Sung Chun Kim, Esq.

2023-3484 05/01/2023 POINT72

2023-3485 05/01/2023 POINT72

2023-3488 05/01/2023 FOI Services, Inc.

2023-3489 05/01/2023 MPG Operations LLC

2023-3492 05/01/2023 Athenex, Inc.

2023-3493 05/01/2023 Athenex, Inc.

2023-3494 05/01/2023 BLOOMBERG NEWS

2023-3500 05/01/2023 Dolat Capital Market Limited

2023-3501 05/01/2023 SIRI & GLIMSTAD LLP

2023-3506 05/01/2023 SIRI & GLIMSTAD LLP

2023-3507 05/01/2023 SIRI & GLIMSTAD LLP

2023-3508 05/01/2023 FOIA Professional Services

2023-3509 05/01/2023 SIRI & GLIMSTAD LLP

2023-3510 05/01/2023 Revance Therapeutics, Inc.

2023-3517 05/01/2023 Redica Systems

2023-3518 05/01/2023 Redica Systems

2023-3519 05/01/2023 Redica Systems

2023-3520 05/01/2023 Redica Systems

2023-3521 05/01/2023 Redica Systems

2023-3522 05/01/2023 Redica Systems

2023-3523 05/01/2023 Redica Systems

2023-3524 05/01/2023 Redica Systems

2023-3525 05/01/2023 Redica Systems

2023-3526 05/01/2023 Redica Systems

2023-3530 05/01/2023 FDAZILLA

2023-3532 05/01/2023 Brown & Crouppen, P.C.

2023-3533 05/01/2023 FOI Services, Inc.

VATT Institute for Economic

2023-3536 05/01/2023 Copenhagen Trial Unit

2023-3540 05/01/2023 FOI Services, Inc.

2023-3541 05/01/2023 FOX ROTHSCHILD LLP

2023-3542 05/01/2023 FDAZILLA

2023-3564 05/01/2023 Bridge Regulatory Affairs, LLC

2023-3565 05/01/2023 Ocular Therapeutix Inc.

2023-3566 05/01/2023 Pour-Rastegar, Terri

2023-3567 05/01/2023 Greenfare Law LLP

Washington Universtiy in St.

2023-3573 05/02/2023 Freelance journalist/author

2023-3577 05/02/2023 Denise Hannigan

2023-3580 05/02/2023 Sheehan and Associates, P.C.

2023-3582 05/02/2023 REUTERS

2023-3584 05/02/2023 FDAZILLA

2023-3589 05/02/2023 Souza, Marcio

2023-3590 05/02/2023 Registrar Corp

2023-3591 05/02/2023 DLA PIPER LLP US

2023-3592 05/02/2023 The Epoch Times

2023-3593 05/02/2023 Aeon Respire INC.

2023-3595 05/02/2023 Registrar Corp

2023-3596 05/02/2023 Registrar Corp

2023-3597 05/02/2023 Registrar Corp

2023-3598 05/02/2023 Registrar Corp

2023-3599 05/02/2023 Registrar Corp

2023-3600 05/02/2023 Registrar Corp

2023-3601 05/02/2023 Registrar Corp

2023-3604 05/02/2023 ELI LILLY & CO