FDA FOIA Closed Log Jan 2022

Control # From
2017-8838 QFI
2017-9176 Contract In-House Counsel and Consultants, LLC
2018-1733 FDAZILLA
2018-5684 Iris Hewlett

2018-6190 LABORATOIRES URGO
2018-6201 STRYKER SUSTAINABILITY SOLUTIONS
2018-7448 Kaiser Health News
2018-8033 Johnson Research

2018-8117 DMETEC Co.,LTD
2018-8982 David Tenenbaum
2018-9160 WHEELER TRIGG O'DONNELL LLP

2018-9217 BARCLAYS
2019-1400 Fresenius Kabi USA
2019-1765 Jordan Smith

2019-1851 FOI SERVICES, INC, *
2019-2231 COVAL-GOLDSMITH, SHERRIE
2019-2232 COVAL-GOLDSMITH, SHERRIE
2019-2986 BD
2019-3042 Steptoe & Johnson LLP

2019-3400 Acknowledge Regulatory Strategies
2019-3599 HINSHAW & CULBERTSON
2019-3851 Peter Strzepa
2019-4411 WEST PHARMACEUTICAL
2019-4566 Eli Lilly and Company
2019-5430 Alltech, Inc.
2019-6371 Austin Research Labs Corp.

2019-6671 Takahiro Haruyama
2019-7293 Womble Bond Dickinson

2019-8624 FUJIFILM IRVINE SCIENTIFIC INC
2019-8728 FDAZILLA

2019-10310 Apricity Health LLC
2019-10493 Anna Christensen Consulting
2019-10494 Anna Christensen Consulting
2019-10984 JONES DAY
2019-11026 NGK SPARK PLUG CO.,LTD.
2019-11082 HENSON, J DONALD
2019-11425 Abbott Laboratories, Inc
2019-11434 Abbott Laboratories, Inc

2019-11558 Attadale Partners
2019-11721 Buchanan Ingersoll & Rooney PC

2019-11842 BeaconLight Capital LLC
2019-11894 PEOPLE FOR THE ETHICAL TREATMENT OF ANIMALS
2019-11920 Hillrom
2019-11931 Spectrawave
2020-96 Michael Toto
2020-97 Patterson Comer Law Firm

2020-137 WOOD BURDITT GROUP
2020-143 Globizz Corp.


2020-167 ALONSO FERRIGNO ET AL
2020-216 Cohen Milstein Sellers & Toll PLLC
2020-467 PILLSBURY WINTHROP SHAW PITTMAN LLP
2020-505 GRAS Associates
2020-650 GENICON
2020-847 Elevate Oral Care
2020-854 Elevate Oral Care
2020-957 HUTTON & HUTTON
2020-973 OsteoRemedies, LLC
2020-1309 Align Technology, Inc
2020-1459 Point Seventy-Two

2020-2050 MCKEEN & ASSOCIATES PC
2020-3840 BLOOMBERG NEWS
2020-4021 freelance
2020-4197 Cercacor Laboratories
2020-4857 International Medical Industries, Inc.
2020-5924 Caridad Smith

2020-6158 Schulte Roth & Zabel
2020-7149 Blasingame, Burch, Garrard & Ashley, P.C.
2020-7150 Blasingame, Burch, Garrard & Ashley, P.C.
2020-7215 W.L. Gore & Associates
2020-7236 Bandula Wijay/LeoCor Inc.(Previously)
2020-7311 Dan Donahue
2020-8144 Block Imaging International

2020-8407 Caladrius Biosciences, Inc.

2021-207 MAZZA HEALTHCARE

2021-591 FUJIFILM Medical Systems U.S.A., Inc.
2021-725 OrthoFX
2021-1044 CNMED CONSULTANT
2021-1081 STRYKER INSTRUMENTS
2021-1457 SonoMotion, Inc.

2021-1488 FOLEY & LARDNER LLP
2021-1737 Rachel Premack
2021-1997 DePuy Mitek

2021-2471 CapsoVision, Inc.
2021-2542 mdi Consultants, Inc.

2021-2639 Jeremy Wiygul
2021-3571 Southern Med Law
2021-3686 Rochester Institute of Technology - Mechanical Engineering

2021-3747 Lince Consulting
2021-3757 SI-TECHNOLOGY, LLC
2021-3790 Robbins LLP

2021-3886 Imangel Consulting
2021-4017 HENKE SASS WOLF OF AMERICA INC
2021-4091 Ohio State University
2021-4153 Kaiser Health News

2021-4179 Stewart Smith Law
2021-4454 LONDON SCHOOL OF ECONOMICS AND POLITICAL SCIENCE
2021-4633 Tremeau Pharmaceuticals, Inc.

2021-4670 Immundiagnostik AG
2021-4705 John Kinchen

2021-5058 Asteelflash Suzhou Co., Ltd.
2021-5254 Method Mobility, Inc.

2021-5271 Drug Device Consulting
2021-5367 WR Medical Electronics
2021-5497 Dr. Laurie Coger
2021-5576 TruthCures Inc.

2021-5619 Lee, Jingyoung
2021-5653 Teva Pharmaceuticals
2021-5736 FDAZILLA
2021-5839 CooperSurgical, Inc.
2021-5922 Star Fish Inc.

2021-5927 Everly Health
2021-6186 Shenzhen Smoore Technology Limited
2021-6215 GVI Clinical Development Solutions

2021-6258 Cutter Law P.C.

2021-6517 Schmidt & Copeland LLC
2021-6643 Cassandra Phillips

2021-6660 COGENCY GLOBAL INC.
2021-6663 Quattlebaum, Grooms & Tull PLLC

2021-6680 Levin Simes Abrams LLP
2021-6790 NORBROOK INC
2021-6803 Jabil Inc

2021-6826 Clayton Trial Lawyers PLLC

2021-6981 DRT Strategies, Inc.
2021-6985 Wondery
2021-7046 Altria Client Services LLC
2021-7057 FOIA Professional Services
2021-7082 MUSCULOSKELETAL TRANSPLANT FOUNDATION

2021-7100 LOEB & LOEB LLP
2021-7116 Sung Chun Kim, Esq.
2021-7143 Valiant Capital
2021-7203 OREGON STATE UNIVERSITY
2021-7204 OREGON STATE UNIVERSITY
2021-7208 Posada Taddeo Dietiker

2021-7211 Dane Thompson
2021-7217 Centaur Pharmaceuticals Pvt. Ltd.
2021-7336 Wake Forest School of Medicine
2021-7347 The USVA

2021-7399 Janssen vaccines

2021-7415 SORGI, LEONARD S
2021-7422 FDAZILLA
2021-7430 University of Missouri Law Library

2021-7487 FOIA GROUP INC

2021-7524 Sirtex Medical Ltd.
2021-7548 Kleinfeld Kaplan and Becker LLP
2021-7573 Morgan Law Firm, Ltd.
2021-7574 Stoll, Daniel W

2021-7575 JH Miles and Associates

2021-7653 Barry Bennett

2021-7703 Speid & Associates, Inc.
2021-7729 Robbins Geller Rudman & Dowd LLP
2021-7757 Wiley LLP
2021-7758 Wiley LLP
2021-7766 Center for Regulatory Services, Inc,
2021-7782 Import Compliance
2021-7809 FDAZILLA
2021-7825 Kerry Inc. /Kerry ingredients

2021-7881 Kono Sseisakusho Company Limited
2021-7885 Hyman, Phelps & McNamara, P.C.
2021-7890 Psymposia
2021-7891 Psymposia
2021-7921 Psymposia
2021-7923 Psymposia
2021-7924 Psymposia
2021-7953 Zydus Pharmaceuticals USA Inc.
2021-7980 FDAZILLA

2021-7994 Gonzalez, Cecilia
2021-7998 FDAZILLA
2021-8010 FDA NEWS
2021-8021 Morgan, Lewis & Bockius LLP
2021-8031 Medela LLC

2021-8036 mctlaw
2021-8052 FDA NEWS
2021-8068 FDAZILLA
2021-8086 Tatiana Walk-Morris
2021-8126 CMC Pharma GmbH
2021-8128 SCOTT+SCOTT Attorneys at Law LLP
2021-8130 Systematix Shares and Stocks
2021-8131 Systematix Shares and Stocks
2021-8132 Perfect Pharmaceutical Consultants

2021-8134 REACH24H USA INC.
2021-8136 Clarivate Analytics (France) SAS
2021-8168 GOODKNECHT, LEROY J

2021-8169 News 5 - WEWS

2021-8176 Tom Namsavanh
2021-8190 Dr. Farrah Agustin-Bunch

2021-8193 FDA NEWS
2021-8195 FDA NEWS
2021-8196 FDA NEWS
2021-8198 FDA NEWS
2021-8205 FDA NEWS
2021-8206 FDA NEWS
2021-8217 Adagio Therapeutics, Inc.

2021-8225 THE UNIVERSITY OF IOWA, COLLEGE OF LAW
2021-8226 University of Vermont Tobacco Center on Regulatory Science

2021-8242 Mark S. Godec, MD
2021-8254 Kissei Pharmaceutical Co., Ltd.
2021-8257 FDAZILLA
2021-8258 FDAZILLA
2021-8259 FDAZILLA
2021-8265 Muller Brazil, LLP
2021-8274 FDA NEWS
2021-8285 FDAZILLA
2021-8287 FDAZILLA
2021-8291 Acella Pharmaceuticals

2021-8297 Keller and Heckman LLP on behalf of Wages & White dba Triton Distribution
2021-8308 CEUTICAL LABS
2021-8315 FDAZILLA
2021-8316 FDAZILLA
2021-8323 Hyman Phelps & McNamara PC

2021-8333 Triple Ring Technologies
2021-8337 Arent Fox LLP, Attorneys at Law, Washington DC
2021-8345 Whittingham, Claire
2021-8349 Contract In-House Counsel and Consl. LLC

2021-8359 Kahn Swick & Foti, LLC
2021-8362 Cox, Dawne
2021-8363 Viosera Therapeutics

2021-8366 Stradling Yocca Carlson & Rauth, A P.C.
2021-8373 Athenex, Inc.
2021-8378 Stinson LLP
2021-8395 Cosmetic Solutions

2021-8398 FDAZILLA
2021-8408 Telemundo Network
2021-8413 Olympus Corporation of America

2021-8417 Garnett, Elizabeth
2021-8441 Xiromed, LLC

2021-8454 Northside Hospital Atlanta
2021-8459 CLEVELAND CLINIC FOUNDATION

2021-8461 Copyright Clearance Center on behalf of client
2021-8463 Lead by Sales, LLC
2021-8477 Registrar Corp.
2021-8481 FDAZILLA
2021-8485 FDAZILLA
2021-8486 Fearon, Stephen
2021-8487 Fearon, Stephen

2021-8497 FDA NEWS
2021-8500 FDA NEWS
2021-8501 FDA NEWS
2021-8502 FDA NEWS
2021-8503 FDA NEWS
2021-8504 FDA NEWS
2021-8505 FDA NEWS
2021-8515 Driftless Extracts LLC
2021-8518 The Rosen Law Firm, P.A.
2021-8522 Arent Fox LLP, Attorneys at Law, Washington DC

2021-8535 FDAZILLA
2021-8536 FDAZILLA
2021-8541 FDAZILLA
2021-8546 Pacific Northwest Pesticide Consulting
2021-8547 Talusis LLC
2021-8548 Greenleaf Health Inc.
2021-8549 Grifols Plasma Operations - BPC Plasma
2021-8550 NaturAmericas
2021-8551 FH2 Pharma L.L.C.
2021-8552 Physicians Committee for Responsible Medicine (PCRM)

2021-8554 LOPEZ-BERESTEIN, GABRIEL
2021-8556 Benjamin L. England and Associates, LLC

2021-8559 Edenbridge Pharmaceuticals LLC
2021-8580 FDAZILLA
2021-8581 FDAZILLA
2021-8582 FDAZILLA
2021-8584 FDAZILLA
2021-8585 FDAZILLA
2021-8586 FDAZILLA
2021-8587 Axinn, Veltrop and Harkrider LLP
2021-8596 Thompson Barney
2021-8625 Burdock Group Consultants
2021-8626 Den-Mat Holdings Inc

2021-8627 NORTHSIDE HOSPITAL
2021-8631 L.A Vegetable

2021-8653 Odin Pharmaceuticals, LLC
2021-8659 FDAZILLA
2021-8660 FDAZILLA
2021-8666 FDAZILLA
2021-8670 Handelsbanken
2021-8671 Boston University School of Law

2021-8673 Xpro associates, LLC
2021-8674 Xpro associates, LLC
2021-8695 FDAZILLA
2021-8699 FDAZILLA
2021-8701 FDAZILLA
2021-8702 FDAZILLA
2021-8705 FDAZILLA
2021-8708 Carnegie Pharmaceuticals LLC
2021-8720 Adamis Pharmaceuticals
2021-8735 BALYASNY ASSET MANAGEMENT

2021-8736 BALYASNY ASSET MANAGEMENT
2021-8738 Bernstein Litowitz Berger & Grossmann LLP
2021-8743 SKG Pharma Inc.
2021-8745 BloombergQuint
2021-8746 HOFFMAN, DAVID .

2021-8748 Devakadaksham, Praveen
2021-8749 Svadhyaya Home School

2021-8750 Muller Brazil, LLP
2021-8751 Gland Pharma Limited
2021-8752 Shaun Mehra
2021-8753 Curadel Surgical Innovations
2021-8754 Balyasny Europe Asset Management LLP

2021-8755 Balyasny Europe Asset Management LLP
2021-8763 FDAZILLA
2021-8764 FDAZILLA
2021-8765 FDAZILLA
2021-8767 FDAZILLA
2021-8770 FDAZILLA
2021-8775 Kleinfeld, Kaplan & Becker, LLP
2021-8776 Point Seventy-Two

2021-8777 HOGAN LOVELLS US LLP
2021-8778 Immunovant, Inc.

Harvard Medical School Department of Population Medicine and Harvard Pilgrim
2021-8781 Health Care Institute
2021-8783 Guggenheim Securities, LLC
2021-8784 ADAGE CAPITAL MANAGEMENT LP
2021-8785 Aurobindo Pharma USA Inc.

2021-8789 FDAZILLA
2021-8790 FDAZILLA
2021-8793 Tri Locum Partners
2021-8794 FDAZILLA
2021-8797 CAPITAL GROUP COMPANIES INC
2021-8800 REGCON Solutions LLC
2021-8802 Hyman Phelps & McNamara PC
2021-8803 REGCON Solutions LLC

2021-8806 CENTER FOR SCIENCE IN THE PUBLIC INTEREST
2021-8807 mietus, zachary
2021-8835 FDAZILLA
2021-8836 FDAZILLA
2021-8837 FDAZILLA
2021-8838 FDAZILLA
2021-8840 Ipsen Biopharmaceuticals, Inc.
2021-8844 COLUMBIA UNIVERSITY
2021-8845 Bloodworks Northwest

2021-8848 Acuta Capital Partners
2021-8850 Accenture solutions pvt ltd
2021-8853 BAILEY GLASSER LLP

2021-8868 The Microbiome c/o Steven Solomon
2021-8872 Amy's Kitchen

2021-8876 Wegmans Food Markets, Inc.
2021-8890 FDAZILLA
2021-8891 FDAZILLA

2022-8 FDAZILLA
2022-9 FDAZILLA
2022-10 FDAZILLA
2022-13 FDAZILLA
2022-15 Glenmark Pharmaceuticals Inc., USA

2022-17 IPD Analytics, LLC
2022-23 FDAZILLA
2022-26 Harrington Films
2022-27 Quinn Emanuel Urquhart & Sullivan, LLP


2022-33 Duty, Harry
2022-34 Duty, Harry

2022-35 Litzher, Paul
2022-39 University of Passau, Bavaria, Germany
2022-44 Program on Regulation, Therapeutics, and Law

2022-45 Whittingham, Claire
2022-47 CASSIDAY SCHADE LLP
2022-51 Petersen, Mitchell

2022-52 Robbins Geller Rudman & Dowd LLP - Mary Blasy
2022-53 N/A
2022-54 Secure Lead Solutions LLC

2022-55 Keller and Heckman LLP
2022-56 Education for All
2022-57 FDAZILLA
2022-58 FDAZILLA
2022-59 FDAZILLA
2022-60 FDAZILLA
2022-63 Goldman Sachs & Co.

2022-65 Jesse Brodkin
2022-66 FDAZILLA
2022-67 DAMON ELLIOTT 31034-037
2022-68 REMINGER
2022-71 FDAZILLA
2022-72 FDAZILLA
2022-73 FDAZILLA
2022-74 FDAZILLA
2022-75 FDAZILLA
2022-76 Pritzker Hageman P.A.
2022-77 Pritzker Hageman P.A.
2022-78 United Safety Agents LLC

2022-80 Acella Pharmaceuticals
2022-81 Carnegie Pharmaceuticals LLC
2022-84 Hogan Lovells LLP
2022-88 Sheffield, Jason
2022-92 C.H. Robinson Worldwide, Inc. DBA Robinson Fresh
2022-94 Solve Consulting International Pty Ltd
2022-96 Columbia Graduate School of Journalism

2022-97 N/A
2022-99 Harvard Pilgrim Health Care Institute

2022-100 MATHIS, KATE
2022-101 MATHIS, KATE
2022-103 ATL Regulatory Consulting LLC
2022-105 Cosmetic Ingredient Review
2022-106 LATHAM & WATKINS LLP

2022-107 Acuta Capital Partners
2022-108 Allen, Adam
2022-109 Cosentini, Victor
2022-114 GRAS Associates, LLC.
2022-117 FDAZILLA
2022-118 FDAZILLA
2022-120 FDAZILLA
2022-121 FDAZILLA
2022-122 FDAZILLA
2022-124 Ceutical Laboratories, Inc.
2022-125 Athyna Pharma LLC

2022-127 The Mustard Man, Inc.
2022-131 Advocate Lutheran General Hospital
2022-136 CONSUMER REPORTS
2022-137 Miracle Mile Law Group

2022-138 THE RECORD AND USA TODAY
2022-146 Florida Department of Financial Services
2022-151 Lupin Pharmaceuticals, Inc.

2022-153 PFM Health Sciences

2022-180 Jamieson Laboratories Ltd.

2022-186 Harrington Films
2022-187 Harrington Films LLC
2022-193 BTG Specialty Pharmaceuticals
2022-194 Meitheal Pharmaceuticals Inc.

2022-196 CDC
2022-203 Roche Freedman LLP
2022-205 BTG Specialty Pharmaceuticals
2022-213 CAS
2022-214 MIDWEST CENTER FOR INVESTIGATIVE REPORTING

2022-216 Mintz Levin
2022-220 OPTOVUE, INC.
2022-226 FDAZILLA
2022-228 FOI Services, Inc.
2022-229 Sterling Technology, Inc.

2022-230 60 Minutes CBS News
2022-234 Triple Gate Capital
2022-235 PROPHARMA GROUP
2022-236 Wells Fargo Securities, LLC

2022-237 INTERTEK
2022-239 FDAZILLA
2022-241 FDAZILLA
2022-242 FDAZILLA
2022-243 FDAZILLA
2022-244 FDAZILLA
2022-245 FDAZILLA
2022-246 FDAZILLA
2022-250 FDAZILLA
2022-251 FDAZILLA
2022-252 FDAZILLA
2022-253 Schnuck Markets Inc
2022-254 CAPITAL GROUP COMPANIES INC

2022-268 Nordea Bank Denmark

2022-272 IQVIA
2022-273 The Fletcher Firm LLP

2022-274 Papamichael, Michael
2022-278 Granite Microsystems, Inc.
2022-279 FDAZILLA
2022-280 FDAZILLA
2022-281 FDAZILLA
2022-282 FDAZILLA
2022-283 FDAZILLA
2022-286 kaleo, Inc.

2022-287 LOEB & LOEB LLP
2022-288 Ouano, Jeffrey

2022-291 Rishi R.
2022-294 Wilson Sonsini Goodrich & Rosati, P.C.

2022-314 Life Extension
2022-318 Exponent Consulting

2022-321 American Regent, Inc.
2022-323 Duty, Harry
2022-326 Evonik Corporation
2022-332 BloombergQuint
2022-333 Bloomberg News
2022-334 StarKist Co.
2022-337 Miller, Jennifer

2022-338 Vikram, Bhanu
2022-347 FDAZILLA
2022-349 Sterigenics, Los Angeles

2022-355 PilieroMazza
2022-356 POINT72
2022-358 Sharla Winters
2022-360 Jennifer Primeau

2022-362 Renton Prep
2022-366 Strides Pharma Inc.

2022-371 POINT72
2022-372 Nolan Heimann LLP
2022-376 Ipsen Ltd
2022-386 AdverseEvents, Inc.

2022-398 FDA NEWS

2022-412 Walker, Joseph
2022-422 POINT72
2022-423 EXPONENT
2022-425 FDAZILLA
2022-427 POINT72
2022-428 FDAZILLA
2022-429 FDAZILLA
2022-430 FDAZILLA
2022-435 University of Oregon School of Law
2022-436 Slayback Pharma LLC
2022-444 FDAZILLA
2022-451 Medtronic Inc, -Swinnea
2022-453 EMPIRE STATE CONSUMER PROJECT INC
2022-454 EMPIRE STATE CONSUMER PROJECT INC

2022-458 Harris Teeter LLC
2022-459 Belcher Pharmaceuticals, LLC
2022-460 Whole In One LLC

2022-481 Hogan Lovells LLP
2022-486 Octapharma Pharmazeutika Prod. Gmbh
2022-489 Apotex Inc.

2022-494 LARKIN, LOREN
2022-497 CONSUMER REPORTS
2022-500 The New York Times Company
2022-517 FDAZILLA
2022-522 Sus Marie
2022-524 Teva Pharmaceuticals, Inc.
2022-528 Baker Hostetler
2022-531 Capstone Development Services Co, LLC
2022-532 WHOLE FOODS MARKET, INC.
2022-536 SSA
2022-543 MICHELLE E DOLAN
2022-545 Satsuma Pharmaceuticals

2022-549 Steptoe and Johnson LLP
2022-557 Sorgi, Leonardo S
2022-576 PROPHARMA GROUP
2022-578 Hong Kong University of Science and Technology

2022-581 James Colvin
2022-582 PORZIO LIFE SCIENCES
2022-590 FDAZILLA
2022-604 BERMAN AND COMPANY
2022-626 Lassman Law+Policy
2022-635 TOM'S HARDWARD
2022-636 TEGNA
2022-648 THE JOHNS HOPKINS UNIVERSITY
2022-650 Karl Nobert

2022-653 US Biotest, Inc.
2022-673 Cipla USA, Inc.
2022-676 Servier Pharmaceuticals, LLC
2022-706 CHICAGO TRIBUNE
2022-708 Hong Kong University of Science and Technology

Subject
Silicone Devices Affected by WithdRawal of Dow Coming Silastic Materials; Alternative Review Procedure Guidance
ZENGAR INSTITUTE, NEUROPTIMAL CASE #535605 RECS RE CLAIMS
GSK VACCINES SRL, ITALY; ETC ate Range: 12/23/2013 - 10/19/2017
RECS RE SCOTT GOTTLIEB SENIOR ADVISOR FOR FDA, INSIGHT ON HOUSE LABORATORY TESTING APPROVAL KITS
01/01/2003 - 12/31/2007
K153229
K171277
EDWARDS LIFESCIENCES REQUESTS TO PARTICIPATE IN THE ALTERNATE SUMMARY REPORTING RE SAPIAN, SAPIENT XT, ETC
Comparison of Tildipirosin compared to Tulathromycin and controls in the treatment of bovine respiratory disease in feed
lot cattle
K170159
All documents related to the Medical Device Single Audit Program (MDSAP) between FDA and Health Canada making the
MDSAP mandatory for American companies doing business in Canada
PRECISION BIOMETRICS INC - MYO VISION 800 SURFACE EMG SYS, DYNAMIC SURFACE EMG SYS WARNING LTR 11/28/07
ASSUREX HEALTH - CORR WITH FDA RE GENESIGHT TEST 08/01/2016 - 11/07/2018
MC3 INC - MC3 JUGULAR LUMEN CATHETER K180151
Preparation of new guidance on clinical trial requirements for corneal refractive surgery devices
Preparation of guidance on lasers for corneal refractive surgical devices
Memorandum written by Susan Alpert banning FDA clinical studies comparing corneal refractive surgery with wearing
contact lenses or glasses.
ANDA 207868
COOL SCULPTING SYS K160259
COOL SCULPTING SYS K171069
K100947 K093065
The definition of acute repetitive seizures (ARS) used by the FDA for purposes ofgranting orphan drug designation for
certain pharmaceuticals for the potential treatment of acute repetitive seizures or cluster seizures. ETC
K182768
1. Any and all 510(k) device submissions by Spineworks, LLC (Registration Number 3005471884) 2. Any and all 510(k) device
submissions by West Coast Spine and Ortho (Registration Number 3009599080) ;
K170249
K190182
BLA 761055/s-012
Neel Products LLC and all labeling and correspondence associated with Real Heal product
Data submitted for the request of a Categorical Exclusion (CE) for Environmental Impact (EI) for Investigational New Animal
Drug (INAD).
K160864 K160006
Final labeling reviews or other final reviews that describe FDA's decision to remove the "boxed warning" from labels
ORIGIO HANDLING WITHOUT PHENOL, ORIGIO HANDLIG WITH PHENOL K173624
483 for Biologics inspection of Jubilant HollisterStier, LLC ending 06/14/2019 at the location in Spokane WA etc
Documents regarding KASA the Word document templates (not the software or operating systems), reviewer aids and
work-aids for the knowledge aided assessment and structured application being used by CDER/OPQ for CMC review of
applications beginning with ANDA reviews.
Date Range: 01/01/2018 - 10/22/2019; 510(k) filing for the OLeena product by Voluntis/Theraxium;
Date Range: 01/01/2016 - 12/31/2019; All documentation relating to Section 522 Order No. PS18002
Date Range: 01/01/2016 - 12/31/2019; All documentation relating to Section 522 Order No. PS18001
REGENXBIO INC - RGX-314 6/6/17 TO PRESENT
K141804,K151488, K190025, K170255
MEDTRONIC - SSED DOCUMENTS FOR P9980022/S010
Internal Review Record Memos for Q180795, Q180795/S001, Q180795/S002, and Q180795/S003 for Abbott's ARCHITECT
Rubella IgG Pre-Submission and Pre-Submission Supplements. Internal meeting presentation power point slide decks for
Q180795, Q180795/S001, Q180795/S002, and Q180795/S003.
Internal Review Record Memos for CR180369, Beckman Coulter Access Immunoassay System. Internal Meeting
Presentation Power Point Slides for CR180369, Beckman Coulter Access Immunoassay System.
Report linking Device Product Codes to applicable FDA Consensus Standards.
Any supporting documents related to the 2002 “Food and Drug Administration/Center for Veterinary Medicine Report on
the Risk from Pentobarbital in Dog Food”
non-clinical or clinical testing for Ambu A/S products related to gastroenterology such as duodenoscope, colonoscope or
gastroscope
PETA requests the outline of production for the following DTaP vaccine from the following manufacturer: Vaxelis (MCM
Vaccine Company, unknown customer and certificate numbers)
PETA requests the outline of production for the following DTaP vaccines from the following manufacturer: Infanrix,
Pediarix, Kinrix (GlaxoSmithKline Biologicals, Customer number 286, Certificate Number 23-R-0012)
PETA requests the outline of production for the following DTaP vaccines from the following manufacturer: Daptacel,
Quadracel, Pentacel (Sanofi Pastuer, Customer number 349, Certificate Number 23-R-0084)
FDA Report Number 9284389 for an incident involving a Welch Allyn Quinton Treadmill that allegedly was emitting a
burning smell.
Device Classification Name: Catheter, Intravascular, Plaque Morphology Evaluation 510(K) Number: K093993 Device Name:
LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 Applicant: Infraredx, Inc. 34 THIRD AVE, Burlington, MA 01803 -
4414
Correspondence regarding the safety of Anavip.
A list of all MQSA facilities who have been cited for an EQUIP violation as part of their annual MQSA inspection.
certified (with a ribbon) FDA records and/or Sanofi Genzyme records relating to the contamination of lot # 7RSL021 and any
FDA or Sanofi records relating to the root cause of the contamination and/or violations of cGMP's concerning the
contamination of the lot. For your convenience, the Recall Event ID is 78792. The Recall # is Z-0607-2018. The recall lot was
lot # 7RSL021 of Synvisc One, a medical device for injection.
K102973 & K172047
All submitted documents for Device: Dako EnVision FLEX+ Detection System , Manufacturer: DAKO Corporation
All Submitted docs of Device: BenchMark ULTRA system, Establishment: Ventana Medical Systems, Inc., Registered
Establishment Number: 2028492
All submitted documents for P040005, Device: Device for Detection of HER-2/neu Gene Amplification in Human Breast
Tissue, Manufacturer: DakoCytomation Denmark A/S
All submitted documents for Device: Clone V9, Manufacturer: Leica Biosystems
All submitted documents for P140025, Device: Anaplastic lymphoma kinase assay , Manufacturer: Ventana Medical Systems,
Inc.
All submitted documents for P990081, Device: Mouse monoclonal antibody for detection of c-erbB-2 antigen in histological
tissue sections, Manufacturer: Ventana Medical Systems, Inc.
All submitted documents for P980018S010, Device: Dako anti-her2 IHC System, Manufacturer: Dako Denmark A/S
All submitted documents for Device: Cone LN10, Manufacturer: Leica Biosystems
RECALL #Z-0373-2019 - RECS; LIST OF MEDICAL OFFICES OR HOSPITALS THAT RECEIVED RECALLED ITEMS
RESPIRE PINK SERIES, RESPIRE PINK+, RESPIRE MEDICAL, ETC - COMMUICATIONS 1/1/19 TO PRESENT
GRAS Associates requests any and all documents within CFSAN, CDRH and CDER regarding oral safety of polylactic acid (PLA)
and polylactide, including documents containing data or analyses of data.
GRAS Associates requests any and all documents within CFSAN, CDRH and CDER regarding oral safety of poly(lactic-co-
glycolic acid) (PLGA) and poly-lactide-co-glycolide, including documents containing data or analyses of data.
any and all documents within CFSAN, CDRH and CDER regarding oral safety of polyglycolic acid (PGA) and polyglycolide,
including documents containing data or analyses of data.
1. Suspect Medical Device: Genicon Specimen Bag 2. Source: FDA MAUDE Database 3. Case Number: MDR Report Key
7366229 which as also identified as Report Number MW5076072
K150208
K161991
ETHICON ENDO SURGERY ENDOSCOPIC CURVED INTRALUMINAL STAPLER 29MM - AER, CORR 2017 TO PRESENT
DEN180066
Labeling Section(s) of K191990-OSW Aligner System by OSW Manufacturing, LLC.
agency communication or documentation between ICU Medical or Hospira (ICU Medical acquired in Feb 2017) regarding the
Plum IV infusion pump from 1/1/2015 to the present date.
Knowledge-aided Assessment & Structure Application’s (KASA) document templates, reviewer aids and work-aids, used by
CDER/OPQ for CMC review of NDA and BLA applications.
US STEM CELL CLINIC LLC, WESTON, FL - INVESTIGATIONS
communication records between the agency and companies regarding the promotion of unlawful Covid-19 claims on social
media who have received warning letters for products regulated as human drugs
The Pre-Investigative New Drug package filed by British American Tobacco and/or its subsidiary Kentucky Bioprocessing LLC,
regarding the covid-19-vaccine they are producing and want to start clinical trials with. Also any additional or subsequent
documents BAT/KBP has filed, and any correspondence related to the filing. Second, any documents or correspondence
filed by Medicago (headquartered in Canada, but with a department in North Carolina), for starting trials regarding their
covid-19-vaccine.
510k: K182041 PMA: P160017
K850051
The complete record for 510(k) K860434 for Chemo vent submitted by IMI.
The complete record for 510(k) K861276 for Versa Fill and fill set, submitted by IMI. This the original submission submitted
by our company in 1986.
The complete record for 510(k) K170672 Tamper Evident Caps for use with ENFit Syringes submitted by International
Medical Industries, Inc including correspondences. This is the original submission submitted by our company in 2017. The
original copy has been misplaced. An electric copy is preferred but paper is acceptable.
The complete record for 510(k) K173577 Guarded Luer Connector submitted by International Medical Industries, Inc
including correspondences. This is the original submission submitted by our company in 2017. The original copy has been
misplaced. An electric copy is preferred but paper is acceptable.
The complete record for 510(k) K182545 Tamper Evident Caps with Male Luer Lock submitted by International Medical
Industries, Inc including correspondences. This is the original submission submitted by our company in 2018. The original
copy has been misplaced. An electric copy is preferred but paper is acceptable.
The complete record for 510(k) K190305 Additive Cap submitted by International Medical Industries, Inc including
correspondences. This is the original submission submitted by our company in 2019. The original copy has been misplaced.
An electric copy is preferred but paper is acceptable.
I would like a copy of the following 510(k) submissions - K111949, K121976, and K140343 - regarding the Aesculap®, Inc.
products for Histoacryl, Histoacryl Blue and Histoacryl Flexible Topical Skin Adhesives.
JUNO THERAPEUTICS, WA - INSPECTION RECS; ETC
•The entire 510(k) file submitted to the FDA for the Parietex Composite Ventral Patch (K120506)
•The entire 510(k) file submitted to the FDA for the Parietex Composite Mono Pm Mesh (K081126)
FDA 483 inspection records for Glaukos facilities, including San Clemente, CA, and Burlington, MA
PMA Number P890001 S012 , PTCA Balloon Angioplasty Catheter by LeoCor Inc. Houston, Texas
All documents and correspondence related to Henry Ford Hospital and Dr. John E. McKinnon from Detroit MI related to
their application for an Emergency Use Authorization (EUA) and IND request for Hydroxychloroquine to be used as
prophylaxis and prevention of COVID-19.
Please provide the accession numbers for GE Healthcare x-ray modalities this includes- computed tomography,
radiographic, fluoroscopy, mammography, interventional radiology (cath & angiography)
Please provide us the accession numbers for GE OEC Medical Systems, Inc. In particular for fluoroscopy systems (c-arms)
Please provide us with the accession numbers for Siemens Healthcare & Siemens Medical Solutions fluoroscopy,
radiography, mammography, general x-ray, cath & angiography, PET/CT systems
For IND 011931, all submissions from sequence 0000 to sequence 0049 and correspondence sent between the sponsor
(Douglas W. Losordo) and the FDA. Caladrius Biosciences, Inc. is the new owner/sponsor of this IND and requests these
records so that we are compliant with required records to be kept by the sponsor under 21 CFR 312.57.
Copy of the disclosable portions of all electronic communications between the FDA and Penumbra regarding K202251,
Penumbra System (Penumbra JET 7 Reperfusion Catheter with Ultra Flex Technology; Penumbra JET 7MAX)
List of IHCTOA letters from CBER to HCT/P manufactureres 11/01/2017 - Present.
Please provide the disclosable portions of any and all documents related to FDA Center for Tobacco Product’s criteria for or
process of prioritizing its review of premarket tobacco product applications (PMTA) for deemed tobacco products subject to
the September 9th, 2020 filing deadline
Copy of the disclosable portions of the EIR for the 12/21/2017 inspection of 3M, located in St. Paul, MN. Please note that
this inspection pertains to devices.
I 1) COSMAN MEDICAL: Cosman G4 Radiofrequency Generator 510(K) Number: K082051

https://www.bostonscientific.com/en-US/products/nerve-radio-frequency-ablation/g4-rf-generator.html 2)
Abbott(NEUROTHERM, INC): NT2000iX Radiofrequency Generator 510(K) Number: K111576
https://www.neuromodulation.abbott/us/en/hcp/products/radiofrequency-chronic-pain/NT2000iX-radiofrequency-
generator.html
CLIA Waiver by Application CW160016 (Parent Document Number K162438)
K192596
510K application document K113422
Document request for 510(k) # K193120. Full files as cleared on 02/14/2020 excluding information deemed confidential.
Please provide the disclosable portions of any Center for Tobacco Products documents (e.g., work instructions, checklists,
procedures) that describe how CTP is now prioritizing applications (Substantial Equivalence, Exemption from Substantial
Equivalence, Premarket Tobacco Applications) submitted by September 9, 2020 ETC
Item #1 ---- Full 510(k) submission document for k131817; Suzhou Xixin Medical Instruments Extracorporeal shock wave
lithotripter; CS-2012A-3 .... and ..... Item #2 --- Full 510(k) submission document for k032958; United Medical Systems
Extracorporeal shock wave lithotripter; Piezolith 3000
Request for a Copy of the Investigational New Drug Application IND 75,736, and All Related Correspondence for the IND
Sponsor, Sonescence, Inc. Cefazolin and Silberg TPS Mettler ME800
I am seeking copies of any and all internal reports containing the phrases “WEN Cleansing Conditioners,“ "WEN by Chaz
Dean Cleansing Conditioner," or "WEN" from July 25, 2016 through November 11, 2017.
Requesting EIRs for the following Labs: Northview Pacific Laboratories, Inc J&J Corporate Biomaterials Center A Division of
Ethicon, Inc. NAMSA 6750 Wales Road North wood, OH 43619-1011 NAMSA 2261 Tracy Road Northwood, OH 43619-1397
NAMSA 115 chemin de I'lsion 38670, Chasse-sur-Rhone FRANCE etc
Requesting traditional 510k data submission for K180732
I need electronic copy of the complete 510(k) for: K#122424 The ISUS Implant Suprastructure K#173466 Panthera Dental
Milled Bars
The 510k applications with the following numbers. K972723 K002617 K023305 K990041
All records related to the analysis of microcracks and product failure/ root-cause analysis in the recalled product da Vinci Si
EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 - manufactured by Intuitive Surgical, Inc. - Recall number
Z-3024-2018 Recall Event ID 80696 510k Number: K180033 K050369 etc.
We are requesting the redacted pre-market approval submission summaries and related communications for the following
devices: K073707, K912723, K902114, K092148, K032226
Seeking 510(k) K140151
K961901
K971782
documents relating to inspections of manufacturing facilities owned and operated by Emergent BioSolutions, Inc. and its
subsidiaries and affiliates.
510(k), K170629 limit to TOC and Performance Bench Testing section.
510(k): K171011, PENTAX Medical VIVIDEO ENT Videoscope Solution
I am a researcher at the Fisher College of Business, The Ohio State University. In my paper on causes of the drug shortages
in the USA I need information about Drug Complexity, Number of Competitors, and Markets size at drug level from
1/1/2012 to 1/1/2021 by calendar quarter
Kaiser Health News seeks copies of FDA pre-approval inspection and pre-licensure reports as well as any follow-up
communication for the two FUJIFILM Diosynth Biotechnologies North Carolina plants. The addresses of the plants: 101 J
Morris Commons Ln, Morrisville, NC 27560 and 6051 George Watts Hill Dr, Durham, NC 27709.
RECS RE VELVET ICE CREAM COMPANY
K800666 Quik-Temp submitted by Liquid Crystal Products
records regarding VACCINES For the following SNOMED CT Indication disease terms: 43489008 |Congo-Crimean
hemorrhagic fever (disorder)| 37109004 |Ebola virus disease (disorder)| 77503002 |Marburg virus disease (disorder)|
19065005 |Lassa fever (disorder)| 721779001 etc
All records related to withdrawal request of Vioxx (rofecoxib) from PREA Postmarket Requirement made by sponsor (Merck
Sharp and Dohme Corp). See attached request letter for Postmarket Requirements and Commitments database details.
Requested records include initial withdrawal request submitted in 2017 and subsequent FDA acknowledgment document.
k162298 Clinical and Performance data used for the determination of substantial equivalence
CONTRACTS RECORDS
documents regarding the CTP's evaluation of PMTAs.
All correspondences, notes, meeting minutes, data, records, rationale, justifications, and related materials pertaining the
following 510(k): K100947.
All correspondences, records, supporting evidence, notes, meeting minutes, data, rationale, and related materials pertaining
to the 510(k) for the following product: K093065
Asteelflash Group/Asteelflash Suzhou Co China RRA between February 22, 2021 and March 16, 2021.
K142482 The Vest Airway Clearance System_x000D_
Full 510K submitted file for device classification Wheelchair, Powered with trade name "Quickie Pulse", 510(k) number
K160031 A .pdf form of this record is preferred. We already have the statement letter for k160031 so we are requesting
the full file.
510(k) submission documents and labels, and FDA review documents of Sea-Band (K033268)
Copy of 510(k) K910624.
I am looking for an adverse event or incident reports related to isoxazoline flea and tick products for pets. These would
include all forms of Bravecto, Nexgard, Credelio, Simparica, Simparica Trio, and Revolution Plus.
All records relating to K894293, including but not limited to communications, manufacturer submissions, supporting
documentation, reviews, predicate device information and determination letters.
K203192(NaviCam Xpress Stomach Capsule Endoscope System)
We are looking to get final approved CARTON LABEL for product XYWAV (CALCIUM OXYBATE; MAGNESIUM OXYBATE;
POTASSIUM OXYBATE; SODIUM OXYBATE, 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML), NDA # 212690. This NDA
was approved on 07/21/2020.
The EIR (in electronic format) for Human Drugs inspection of FujiFilm Diosynth Biotechnologies U.S.A., Inc. ending
04/21/2021 at the location in Research Triangle Park NC, United States. The 483 (in electronic format) for Human Drugs
inspection of Biogen MA Inc. ending 06/16/2021 at the location in Research Triangle Park NC, United States. etc
To whom it may concern, This FOIA request is for the full 510(k) submitted documentation for K914241 (PIONEER PRO-
PUMP DUAL CONTROL) and K914220 (PIONEER PRO-PUMP) from 09/19/1991 to 03/04/1992. Please let me know if you
have any questions. Best regards, Arani Nirmalan
Voluntary Remote Regulatory Assessment (VRRA) Inspected facility: Star Fish Inc. Address: 301 Marine Dr, Blaine, WA 98230
Cleared labeling for Polymedco OC-Auto Sensor DIANA iFOB Test system (K092330)
K171969
K171993
K192908
An unredacted copy of all memoranda or reports of the Remote Regulatory Assessment (RRA), and any other
documentation relevant thereto, that the Office of Compliance and Enforcement (OCE) performed on: Shenzhen Smoore
Technology Limited: No. 16, Dongcai Industrial Zone, Gushu Community, Xixiang Street, Bao’an District, Shenzhen,
Guangdong Province, P.R. China 518102 and Shenzhen Vaporesso Technology Limited: M101-301, Block2, 15th Building,
East Songgang Road, Dongfang Community, Songgang Town, Bao'an District, Shenzhen City, Guangdong Province, P. R.
China 518105 for the Premarket Tobacco Product Applications (PMTAs) submitted under Section 910 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act). The RRA was conducted by Carmen Fisher and Christopher Keating from March 16, 2021
to April 8, 2021.
The 510(k) submission for the IMRIS Neuro II-SE Intra-Operative Magnetic Resonance Imaging System (K061916), filed by
IMRIS Inc, dated July 4, 2006 and cleared on August 11, 2006.
K210936, Elvie Stride
Documents relating to Wages & White Lion Investments LLC dba Triton Distribution and their e-liquids including Premarket
Tobacco Product Applications and related orders, inspections, adverse events, and scientific studies as described in the
attached letter.
K153605, Ivwatch Model 400
Copy of the disclosable portions of the PREA Post-Marketing Study Committments for NDA 21290, Naproxen sodium, by
Banner Pharmacaps, for the 02/17/2006 approval. We believe the final report was due 02/18/2009. We are looking for the
final report or a PREA waiver, if one was submitted.
Copies of submissions from Perrigo Pharmaceuticals regarding hypoallergenic infant formula products containing
extensively hydrolyzed protein.
Copy of the disclosable portions of all correspondence between FDA and Pharmaceutics International, Inc (PII) following the
April 16, 2021 and May 19, 2021 letters from PII to FDA regarding Update on Qualification Activities Related to an ANDA
(attached). This information may be part of the files for the October 2020 inspections of PII's Hunt Valley, MD and
Cockeysville, MD facilities.
all material regarding the submission of: - 510(k) Premarket Notification of #K945062 by Kinetics Concepts Inc. - 510(k)
Premarket Notification of #K992448 by Kinetics Concepts Inc.
All internal FDA reviewer guidance, manuals, templates, etc
PMTA APPLICATION
Any Parent’s Choice brand baby food product, including but not limited to Sample 1145091 of Parent’s Choice infant rice
cereal; and Consideration of any Parent’s Choice baby food recalls.
INDIVIDUAL RECS
K061079
We are requesting the analytical tissue residue method for swine for Nuflor-S (NADA 141-063) related to August 19, 2021
approval of additional swine claims to product label. Note, if changes have been made to the cattle method to
accommodate swine, we request the updated cattle method.
Remote Regulatory Assessment (RRA) of Jabil Inc. Benicia facility lead by Aliza Chalapong started Feb 4, 2021, ended March
2, 2021. The RRA was in regards to the Fontem U.S. PMTA. We would like a copy of the final report.
Copy of the disclosable portions of the report prepared by FDA investigator(s) at the conclusion of the Remote Regulatory
Assessment of Pharmacia & Upjohn Company, LLC Located at Kalamazoo MI United States FEI Number: 1810189 held on
03/31/2021. This inspection pertains to drug products.
Assessment of Gilead Sciences, Inc. Located at Foster City CA United States FEI Number: 1000523075 held on 03/19/2021.
This inspection pertains to drug products.
Assessment of Anika Therapeutics, Inc. Located at Bedford MA United States FEI Number: 3007093114 held on 03/26/2021.
This inspection pertains to drug products.
All telephone call logs relating to RCBA Nutraceuticals LLC and/or Ronnie Coleman Signature Series All emails referencing,
mentioning, discussing, and/or identifying RCBA Nutraceuticals LLC and/or Ronnie Coleman Signature Series All letters
referencing, mentioning, discussing, and/or identifying RCBA Nutraceuticals LLC and/or Ronnie Coleman Signature Series All
inspection records of RCBA Nutraceuticals LLC located at 635 Century Point Suite 121, Lake Mary, Florida 32746
Copy of the disclosable portions of the following documents: (1) Mead Johnson Enfinitas New Infant Formula Notification
submitted on or about 10/03/2014; (2) Memo from Jeremy Mihalov (OFAS) to Linda Tonucci (and others) dated 03/19/2015
relating to the use of lactoferrin in infant formula (we believe this is also related to Enfinitas); ETC
K053052 Medela Freestyle
Reviews for PM0000551, PM0000553 and PM0000560, Vuse Solo, by RJ Reynolds.
HHSF223201700023B, HHSF223201810005B, HHSF223201510027B, and HHSF223201510028B.
I'd like to see any/all records (including complaints of adverse effects) from 1/1/2018 - 9/30/2020 pertaining to the
following products: - F-Factor 20/20 Fiber/Protein Powder – Vanilla Flavor - F-Factor 20/20 Fiber/Protein Powder –
Chocolate Flavor - F-Factor 20/20 Plant-Based Fiber/Protein – Unflavored - F-Factor 20/20 Fiber/Protein Powder –
Unflavored - F-Factor Fiber/Protein Bar – Chocolate Brownie - F-Factor Fiber/Protein Bar – Peanut Butter
Reviewer notes regarding EX0001824-PD1
Contract Number: HHSF223201700013B Contract Title: Blanket Purchase Agreement GS35F257DA-HHSF223201700013B
Copy of the disclosable portions of the EIRs and 483s for the following inspections of Mead Johnson (1) Evansville, IN facility:
03/31/2017, 08/16/2017, 08/09/2018, and 08/26/2021; and (2) Zeeland, MI facility: 05/04/2018. Please note these
inspections related to Foods.
Copy of the disclosable portions of the EIRs and 483s for the following inspections of PBM Nutritionals (1) Milton, VT facility:
08/21/2017, 08/15/2019, and 09/28/2020; and (2) Covington, OH: 09/28/2017, 09/28/2018, and 08/23/2019. Please note
these inspections relate to foods.
FMD-145 Letter and EIR for MTF Tissue Services Rochester NY facility FEI: 3011400049 completed in May 2019 sent to
Nancy Simmons and acknowledged June 11, 2019 FMD-145 Letter and EIR for MTF Jessup PA facility FEI: 1000307092
completed July 2019 sent to Joe Yaccarino FMD-145 Letter and EIR for MTF Olyphant PA facility FEI: 3006813973
completed May 2019 sent to Joe Yaccarino August 2019
Documents maintained by the Food and Drug Administration (“FDA”) regarding Bluebird Bio, Inc.’s (“Bluebird”) Biologics
License Application (“BLA”) for betibeglogene autotemcel (“beti-cel”) gene therapy, which was formerly referred to as
LentiGlobin
All correspondence between the FDA and the company FibroGen, headquartered in San Francisco, California, in particular
any material referencing the FDA's denial (via CRL) of FibroGen's new drug application for Roxadustat. In the alternative,
any records produced by FDA in response to FOIA request 2021-5848.
All details related to the FDA's decision declining emergency use authorization for Lenzilumab, including 1) any letters or
correspondences to Humanigen Inc. related to the FDA's decision, 2) individuals who reviewed the EUA application, and 3)
notes or comments from those individuals who reviewed the EUA application.
Infant Formula Submissions for (1) Enfamil Enspire; (2) ByHearts Formula; (3) Enfamil Gentlease; (4) Enfamil Premium A2; (5)
Similac Pro Sensitive; and (6) Gerber Good Start Gentlepro.
I am requesting the NCBI Pathogen Database Isolate numbers (PDT#) and Biosample numbers (SAMN#) for the clinical
Salmonella isolates that were used for the traceback investigation reported in Figure 1 of FDA's "Investigation Report:
Factors Potentially Contributing to the Contamination of Red Onions Implicated in the Summer 2020 Outbreak of Salmonella
Newport".
I am requesting the NCBI Pathogen Database Isolate numbers (PDT#) and Biosample numbers (SAMN#) for all of the
environmental Salmonella isolates recovered from the investigation of the Salmonella Newport outbreak in 2020 in Table 1
in FDA's "Investigation Report: Factors Potentially Contributing to the Contamination of Red Onions Implicated in the
Summer 2020 Outbreak of Salmonella Newport".
We are seeking a copy of the Response made to the Warning Letter re: Tampa FuM Corp. MARCS-CMS 607938 -MAY 12,
2020
FDA-2021-N-1088-0001 PUBLIC COMMENTS
The RLD Halcion 0.25mg - Bottle labels of 100's and 500's pack and 0.125mg - Bottle labels of 10's, 100's and 500's pack is
not available on DailyMed or FDA label repository. If Halcion 0.125mg labeling cannot be provided, kindly arrange the Bottle
labels of 500's pack of Authorised Generic- Triazolam by Greenstone LLC
We are requesting the Center for Tobacco Products’ project report on “natural” as a modified risk claim, specifically in
regards to the brands Natural American Spirit and Nat Sherman
Freedom of Information Act Request for Disclosure of unredacted instructions to staff on decision making of the Marketing
Denial Order (MDO) for Paradigm Distribution STNs PM00000968
Janssen Vaccines requests VAERS reports of confirmed cases of Thrombosis with thrombocytopenia syndrome, acute motor
axonal neuropathy, acute motor-sensory axonal neuropathy, Bickerstaff's encephalitis, chronic inflammatory
demyelinating polyradiculoneuropathy, demyelinating polyneuropathy, Guillain-Barre syndrome, etc
Attn: CDER. Copy of the disclosable portions of a list of all Remote Interactive Evaluations (RIEs) from 01/01/2020 to the
present. Please include the following information: firm & firm address; inspection begin and end date; investigator name;
whether a 483 was issued; and the outcome classification.
NDA 202107
Please provide the following 2 inspection-related documents in electronic PDF format: The EIR (in electronic format) for
Medical Devices & Rad Health inspection of Abaxis Inc ending 08/22/2019 at the location in Union City CA, United States.
The Response (in electronic format) for Medical Devices & Rad Health inspection of Abaxis Inc ending 08/22/2019 at the
location in Union City CA, United States.
(1) I am requesting the attorney’s letter/request and FDA’s response (the advisory opinion) mentioned on this page (note:
this is a request for an advisory opinion, which was probably treated by FDA as akin to a citizen petition): “On June 3, 1986,
an attorney wrote to the Food and Drug Administration ("FDA") on behalf of the publisher of a monthly publication
distributed to physicians that contains entries describing prescribing information for certain drug products. The attorney
requested an advisory opinion on whether FDA would deem the product entries labeling under section 201(m) or
advertising under section 502(n) of the Federal Food, Drug, and Cosmetic Act ("the Act") for those products that were the
subject of a paid advertisement in the same publication. In response to this request, “ https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/cpg-sec-400700-drug-product-entries-periodic-publications (2) a copy of :
Position on the Concept of Solicited and Unsolicited Requests (April 22, 1982) which was issued by what was then called the
Division of Drug Advertising and Labeling. Note: This was a bulletin circulated to the public by the predecessor to
OPDP/DDMAC. (3) a copy of CPG 7132c.02 (1976) from the agency.CPG is the agency’s Compliance Policy Guide. (this is
section 7132c.02 of the Compliance Policy Guide as it appeared in 1976.) Thank you.
For certain applications JMC submitted to CTP, provide the randomly generated numbers assigned to our applications or a
listing that provides the order.
For certain applications PMUSA submitted to CTP, provide the randomly generated numbers assigned to our applications or
a listing that provides the order.
HHSF223201700008B
For certain applications and filings that USSTC has submitted to CTP, provide the randomly generated numbers assigned to
our applications or a listing that provides the order.
axonal neuropathy, acute motor-sensory axonal neuropathy, Bickerstaff's encephalitis, etc
510(k) complete file - K033960 Olinda EXM
All versions of internal Center for Tobacco Products memoranda or other internal guidance documents relating to review of
PMTAs for electronic nicotine delivery systems (ENDS) containing non-tobacco flavored e-liquid, including those related to
evidence to demonstrate benefit of flavored ENDS to adult smokers and other related scientific issues.
Form 483s, Responses to Form 483s, Warning Letters, Responses to Warning Letters and Establishment Inspection Reports
for the business of Advanced Bionics Corporation and Advanced Bionics, LLC at the locations commonly known as 28515
Westinghouse Place, Valencia, California and/or 12740 San Fernando Road, Sylmar, California or any other of its
manufacturing locations.
Any and all records pertaining to the selection of the position Supervisory Consumer Safety Officer: Announcement number
FDA-ORA-21-MP-11077979-MK
75F40121C00053
Please provide a copy of the July 9, 2021 Office of Science memorandum signed by CTP’s Director of the Office of Science,
Matthew Holman, that discusses a “Fatal Flaw” review of premarket tobacco product applications not in Phase III review for
non-tobacco-flavored ENDS products.
Attn CTP: Copy of the disclosable portions of the following documents, which are referenced in the attached memo: The
Premarket Application Review Prioritization plan memo dated 08/31/2020, and the addenda dated 09/24/2020 &
05/11/2021.
PERSONAL RECS
DIA Meeting in 2021 in USA
All documents in the Food and Drug Administration's ("FDA") possession relating to Iterum and its New Drug Application for
oral sulopenem etzadroxil/probenecid (the “sulopenem NDA”) during the specified time period.
Please provide a copy of the disclosable portions of the FDA Center for Tobacco Products Office of Science administrative
and scientific reviewer notes related to all Substantial Equivalence Reports (SE Reports) submitted by British American
Tobacco or Reynolds American (or their subsidiaries) for the product “Glo” and that received a final determination.
I am requesting publicly available, non-confidential documents related to the recycling of agricultural plastic for use as a
feedstock for any type of food packaging application. More information is provided in the attached request letter.
I am requesting publicly available, non-confidential documents related to the recycling of carpet and fiber for use as a
feedstock for any type of food packaging application. More information is provided in the attached request letter.
All releasable information to support the AAFFCO 36.15 Dried Fermentation Biomass , including information provided in
support of the definition and the FDA reviews and correspondence.
We request all disclosable/releasable portions of the Establishment Inspection Report (EIR) of Nestle Mexico, S.A. de C.V.
Lagos Polvos FEI NUMBER 3004256904 with Inspection End Date: 08/10/2017 Inspection ID: 1024412. Additionally, all
records disclosable portions of the records of Field Accomplishment and Compliance Tracking System (FACTS) and eNSpect.
axonal neuropathy, acute motor-sensory axonal neuropathy, Bickerstaff's encephalitis, ETC
Please provide the following 3 inspection-related documents in electronic PDF format: The 483 (in electronic format) for
Animal Drugs & Feeds inspection of Best Formulations Inc ending 09/30/2021 at the location in City Of Industry CA, United
States. The EIR (in electronic format) for Animal Drugs & Feeds inspection of Best Formulations Inc ending 09/30/2021 at
the location in City Of Industry CA, United States. The Response (in electronic format) for Animal Drugs & Feeds inspection
of Best Formulations Inc ending 09/30/2021 at the location in City Of Industry CA, United States. Please send documents as
email attachments.
On behalf of Kerry Inc. I would like to request for expedited FOIA for any and all 483 issued to Kerry facilities in the USA and
any 483’s issued to another company as a result of any Kerry products. If possible, please separate the regulatory violations
and the Food safety violations. feel fee to even use a spread sheet/excel
K011208
A copy of any checklist or similar list used by the Office of Generic Drugs when reviewing the appropriateness and adequacy
of a CBE Supplement (both a CBE-30 and CBE-0) and a Prior Approval Supplement to an ANDA for a site transfer of an
Immediate-Release drug product and for a new API supplier.
K982278
K961100
This is a request under the Freedom of Information Act. I hereby request the following records: Any and all documents, be
they electronic or otherwise, pertaining to preliminary warnings sent to the Multidisciplinary Association for Psychedelic
Studies (MAPS) about clinical trial reports / results that were late or not submitted. etc
This is a request under the Freedom of Information Act. I hereby request the following records: Any and all email
correspondence between executives at the company Compass Pathways and the FDA about Compass Pathways clinical
trials. etc
1,106 Zepatier FAERS Case Reports. Please see attached.
demyelinating polyradiculoneuropathy, etc
Please provide copies of all tobacco related (including cigarette; electronic cigarette; electronic nicotine or vaping product;
or tobacco heating system) product injury/adverse event/reaction reports voluntarily reported to the FDA Center for
Tobacco Products, the FDA Safety Reporting Portal, MedWatch program, and the FDA Adverse Event Reporting System from
February 2021 – November 2021.
We request all the records obtained by FDA in accordance with the FSVP regulation of the "Foreign Supplier’s Safety
Procedures, Processes and Practices Related to the Safety of the Food" for FDA product code 09CEE13
from NESTLEW MEXICO SA DE CV Street Address: Frente Estacion Ffcc, Col. Pueblo De Moya City: Lagos De Moreno Jalisco
50071 México DUNS Number: 81-271-6819 FEI Number: 3014297337.Also, all the information relevant to this kind of
verification activities required by this rule. 21 CFR 1.510(f)
Any and all email correspondence between executives at the company Cybin and the FDA about Cybin’s drug clinical trials.
Any and all documents, be they electronic or otherwise, relating to Cybin’s drug clinical trials. Any and all complaints filed to
the FDA relating to Cybin or Cybin’s drug clinical trials. The requested documents will be made available to the general
public, and this request is not being made for commercial purposes.
This is a request under the Freedom of Information Act. The product area at issue is drugs and drug clinical trials. I hereby
request the following records: Any and all email correspondence between executives at the company GH Research and the
FDA about GH Research’s drug clinical trials. Any and all documents, be they electronic or otherwise, relating to GH
Research’s drug clinical trials. Any and all complaints filed to the FDA relating to GH Research or GH Research’s drug clinical
trials.
The product area at issue is drugs and drug clinical trials. I hereby request the following records: Any and all email
correspondence between executives at the company MindMed and the FDA about MindMed’s drug clinical trials. Any and
all documents, be they electronic or otherwise, relating to MindMed’s drug clinical trials. Any and all complaints filed to the
FDA relating to MindMed or MindMed’s drug clinical trials.
Please provide Summary Basis of Approval of MYRBETRIQ GRANULES (mirabegron for extended-release oral suspension) 8
mg/mL for the Applicant ASTELLAS PHARMA GLOBAL DEVELOPMENT INC- N213801
Please provide the following 1 inspection-related documents in electronic PDF format: The Response (in electronic format)
for Medical Devices & Rad Health inspection of Abbott Laboratories Inc. (St Jude Medical) ending 03/29/2019 at the location
in Saint Paul MN, United States. Please send documents as email attachments.
demyelinating polyradiculoneuropathy, demyelinating polyneuropathy, Guillain-Barre syndrome, Miller Fisher syndrome,
etc
We would like to request the full audit report from the audit made on July 2015 to Global Protection Corp.
Human Drugs inspection of BioMarin Pharmaceutical, Inc. ending 12/14/2017 at the location in Novato CA, United States.
The Response (in electronic format) for Human Drugs inspection of BioMarin Pharmaceutical, Inc. ending 12/14/2017 at the
location in Novato CA, United States. etc
Copies of Form 483s issued to the following DRUG companies in June, 2021.
All submission documents related to the 510(k) Premarket Notification K202416 that are releasable under the Freedom of
Information Act.
510(K) Number:- K210936 | Device Name:- Elvie Stride | Applicant:- Chiaro Technology Limited, 2nd Floor 63-66 Hatton
Garden, London, GB Ec1n 8le | Device Classification Name:- Pump, Breast, Powered | Regulation Number:- 884.5160 |
Classification Product Code: -HGX
demyelinating polyradiculoneuropathy, demyelinating polyneuropathy, Guillain-Barre syndrome, Miller Fisher syndrome,
subacute inflammatory demyelinating polyneuropathy, etc
Request for report related to VAERS ID# 846221. Please see the attached request and signed authorization.
Copies of Form 483s issued to the following DEVICE companies from July 1-31:
Human Drugs inspection of Nypro Inc. ending 03/21/2014 at the location in Clinton MA, United States. The EIR (in
electronic format) for Human Drugs inspection of Nypro Inc. ending 03/21/2014 at the location in Clinton MA, United
States. ETC
I'd like to request consumer complaints filed between May 7, 2020 and Nov. 22, 2021, citing adverse health effects or
misleading health claims related to COVID-19 cures against the companies that have and have not received a warning letter
for promoting false COVID-19 cures between March 6, 2020 and Nov. 1, 2021.
EIR (Establishment Inspection Report) SYNLAB Analytics & Services Germany GmbH Standort Aachen Auf der Hüls 183,
Aachen, Germany, FEI Number 3014435713 Inspector: Toni F. Bernard
1. The Complete Response Letter issued to Athenex by the FDA regarding Athenex’s New Drug Application for oral
paclitaxel plus encequidar for the treatment of metastatic breast cancer. 2. Any and all communications between the FDA
and Athenex from July 1, 2019 through November 1, 2021, regarding: a) the Complete Response Letter; and b) oral
paclitaxel plus encequidar for the treatment of metastatic breast cancer.
This is a request under the Freedom of Information Act. I request a copy of Form 483 for Veeda Clinical Research Shivalik
facility located in Ahmedabad India for their latest inspection conducted in last 12 months
This is a request under the Freedom of Information Act. I request a copy of Form 483 for Veeda Clinical Research Vedant
facility located in Ahmedabad India for their latest inspection conducted in last 12 months
Teena Biolabs Pvt Ltd, Bachupally India Seeking Inspection Classification (VAI,NAI,OAI) ?? inspection dates 2/07/2018 -
2/9/2018 and any subsequent inspections."
We are seeking for full FCN information of the following 2 FCN dossiers: FCN 1835 FCN 1119
As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483:
LightStone Medical Llc Brooklyn, NY End Dates of inspection: 25 June 2021 Project Area: Postmarket Assurance: Devices
District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request, however please
contact me if the charges exceed $ 200.
McNeil Healthcare, LLC Las Piedras, PR End Dates of inspection: 31 March 2021 Project Area: Compliance: Devices District
Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request, however please contact
me if the charges exceed $ 200.
I am requesting all information CVM can provide about adverse events reported to CVM for Claro Otic Solution (florfenicol,
terbinafine, mometasone furoate; NADA 141-440) from September 25, 2015 to present (November 25, 2021.)
Any records of FDA investigations into company named BioCorRx
We request all the records obtained by FDA in accordance with the FSVP regulation of the Foreign Supplier’s Safety
Procedures, Processes and Practices related to the safety of the food manufactured in Conservas La Costena, S.A. De C.V.
Calle Via Jose Maria Morelos # 268 Pueblo La Purisima Tulpetlac Ecatepec De Morelos. Mexico. FEI 3008153698. FDA
Product Code 24FEI12. Also all the information relevant to this kind of verification activities required by 21 CFR 1.510(f
We request all the records obtained by FDA in accordance with the FSVP regulation of the Foreign Supplier’s Safety
Procedures, Processes and Practices related to the safety of the food manufactured in Barcel Occidente, Calle 13 Num 440
Ampl. Valle Del Alamo, Guadalajara Jalisco, Mexico FEI 3012331453. FDA Product Code 07BGT02. Additionally, all the
information relevant to this kind of verification activities required by 21 CFR 1.510(f).
Domestic and foreign 483s, responses to 483s and EIRs.
I'm seeking the complaints that were received by FDA which resulted in the warning letter MARCS-CMS 612282 — APRIL 21,
2021 addressed to my company DRF LLC.
We request all disclosable/releasable portions of the Establishment Inspection Report (EIR) of Compania Embotelladora del
Fuerte,S. de R.L. de C.V. FEI Number 3013267007 ended 8/20/2018 with an Inspection ID: 1067656. Additionally, all records
disclosable portions of the records of Field Accomplishment and Compliance Tracking System (FACTS) and eNSpect.
Copies of Form 483s issued to the following DEVICE companies on the indicated date.
Copies of Form 483s issued to the following DRUG companies on the indicated date.
Copies of Form 483s issued to the following CLINICAL INVESTIGATORs on the indicated date.
Copies of Form 483s issued to the following CLINICAL INVESTIGATORs on the indicated date.
Forms 483/Clinical Investigator/Lydie L. Hazan/Los Angeles, California
axonal neuropathy, acute motor-sensory axonal neuropathy, Bickerstaff's encephalitis, chronic inflammatory etc
reports of adverse health effect records of humans exposed to Altrenogest
Response to letter from Vermont Tobacco Center for Regulatory Science at the Vermont Center on Behavior and Health
submitted a letter to the Center for Tobacco Products dated October 20, 2016
Please provide additional information for VAERS ID#1862529
I request consumer complaints 306210645, 306220735, 10360957 and 10360958 cited in Form 483 for FEI #2518422
(inspection end date 11/9/2021) involving Philips Respironics CPAP devices and ventilators.
Established Inspection Reports for the GLP inspection on the facilities listed below; 1. BioReliance Address: 9630 Medical
Center Drive Rockville, MD 20850, US Applicable inspections: 7/28/2003 Bioresearch Monitoring, CDER [NAI] 9/7/2010
Bioresearch Monitoring, CDER [VAI] 2/4/2011 Bioresearch Monitoring, CDER [VAI] 2 ETC
for Human Drugs inspection of Dr. Reddy's Laboratories New York, Inc. ending 03/03/2021 at the location in Middleburgh
NY, United States. Please send documents as email attachments.
Foods & Cosmetics inspection of Whitmore Family Enterprises, LLC dba Taza Chocolate ending 10/13/2014 at the location in
Somerville MA, United States. The EIR (in electronic format) for Foods & Cosmetics inspection of Whitmore Family
Enterprises, LLC dba Taza Chocolate ending 10/13/2014 at the location in Somerville MA, United States. Please send
documents as email attachments.
Human Drugs inspection of Arifulla Khan MD ending 06/11/2014 at the location in Bellevue WA, United States. The EIR (in
electronic format) for Human Drugs inspection of Arifulla Khan MD ending 06/11/2014 at the location in Bellevue WA,
United States. etc
VAERS Report
Foods & Cosmetics inspection of East West Tea Company, LLC ending 05/19/2011 at the location in Eugene OR, United
States. The Response (in electronic format) for Foods & Cosmetics inspection of East West Tea Company, LLC ending
05/19/2011 at the location in Eugene OR, United States. Please send documents as email attachments.
Biologics inspection of National Genetics Institute ending 01/19/2017 at the location in Los Angeles CA, United States. The
EIR (in electronic format) for Biologics inspection of National Genetics Institute ending 01/19/2017 at the location in Los
Angeles CA, United States. The EIR (in electronic format) for Biologics inspection of National Genetics Institute ending
12/04/2018 at the location in Los Angeles CA, United States. The Response (in electronic format) for Biologics inspection of
National Genetics Institute ending 12/04/2018 at the location in Los Angeles CA, United States. Please send documents as
email attachments.
ALL FORM 483, EIR, RESPONSE LETTERS, AND ANY OTHER COMMUNICATIONS WITH THE FDA BY/FOR AKORN
PHARMACEUTICALS LOCATED AT 150 South Wyckles Road, Decatur, Illinois (IL) 62522
Review Memorandum and Correspondence related to Innevape PMTA
Inspection records of BPI Sports in Fort Lauderdale, Florida Please include both 483 and EIR records I understand ORA
performed an inspection on 8/12/21. Thank you to the Orlando Office for the inspection. BPI Sports 3149 SW 42nd
Street, Suite 200 Fort Lauderdale, Florida 33312-6802 Thank you, Courtland
Human Drugs inspection of Morie A. Gertz, M.D., Clinical Investigator ending 03/09/2018 at the location in Rochester MN,
United States. The Response (in electronic format) for Human Drugs inspection of Morie A. Gertz, M.D., Clinical Investigator
ending 03/09/2018 at the location in Rochester MN, United States. Please send documents as email attachments.
Human Drugs inspection of Patheon Pharmaceuticals Inc ending 12/13/2019 at the location in Cincinnati OH, United States.
The EIR (in electronic format) for Human Drugs inspection of Xellia Pharmaceuticals USA LLC ending 10/13/2016 at the
location in Bedford OH, United States. Please send documents as email attachments.
A copy of the Approval Letter for ANDA 215037 for Nelarabine Injection, 250 mg/50 mL (5 mg/mL), approved on November
17, 2021.
demyelinating polyradiculoneuropathy, demyelinating polyneuropathy, Guillain-Barre syndrome, ETC
complete 510(k) copies for K163457, K162741, K152967
Food Contact Notification (FCN) No. 2160 (BASF)
all inspection documents for FDA inspection of Answers Pet Food, Lystn LLC, located at 356 Maidencreek Rd, Fleetwood, PA
19522 11.01.21-11.30.21
Please provide Al Khalifa’s Premarket Tobacco Product Applications (PMTAs) (assigned Submission Tracking Number
PM0002037).
COMMUNICATIONS WITH ALTRIA
Average Daily Intakes of heavy metals for foods
Adagrasib (MRTX849) FDA Pharmacokineticists' reviews and medical officers' reviews, especially data related to tissue drug
concentrations.
Chemistry and Toxicology review memoranda for FCN 2142
Establishment Inspection Report for the inspection of World Nutrition, lnc. located in Scottsdale, Arizona arising from the
inspection conducted on July 26, 2018 – July 27, 2018 by Derek S. Dealy (FEI Number 3005067299).
FDA inspection report for Intrinsic Imaging, with the specifications below: Inspection reason: Intrinsic Imaging Study 150209
– Athenex Protocol KX-ORAX-001 Inspection dates: January 4-7, 2021 Inspection location: Intrinsic Imaging LLC 580 Main
Street, Suite 210, Bolton, MA
(1) Form 483 inspection report dated March 23, 2021 relating to Adamson Analytical Laboratories (the Corona, CA, facility);
(2) Adamson Analytical Laboratories April 13, 2021 Response to the Form 483; (3) FDA's August 17, 2021 Warning letter to
Adamson Analytical Laboratories
demyelinating polyradiculoneuropathy,etc
I would like to request all the FDA site inspection reports since 2016 for a company in Taos, New Mexico- Private Label
Select- 1320 Paseo Del Pueblo Sur, Taos, New Mexico (NM) 87571, United States (USA). FEI is 3000204154 DUNS is
005415463
Biologics inspection of Rockefeller Fertility Center ending 11/05/2021 at the location in New York NY, United States. Please
send documents as email attachments.
I need please to get a detailed list of all the complaints or issues reported to the FDA of the drug YKP3089 of the company
SK Life Science Inc. Please include complains of all clinical trial phases and also during the years that the medicine was
approved and went to the market. _x000D_
_x000D_
Olympus would like to request the full 510(k) file for K190303, cleared on 2/12/2019. The subject device is the Airseal
Insufflator, manufacturer is ConMed Corporation. Olympus would like to see the test plans for the device.
VAERS RECS
Copy of the disclosable portions of the Food Additive Petition and all FDA reviews for FAP 2B4333, regarding poly(p-
oxyphenylene poxyphenylene p-carboxyphenylene) resins as a component of food-contact articles intended for repeated
use.
Summary Basis of Approval (SBOA) for two (2) related abbreviated new drug applications (ANDAs): ANDA 203594:
Drospirenone, Ethinyl Estradiol, and Levomefolate Calcium Tablets, 3 mg/0.03 mg/0.451 mg and Levomefolate Calcium
Tablets, 0.451 mg ANDA 203593: Drospirenone, Ethinyl Estradiol, and Levomefolate Calcium Tablets, 3 mg/0.02 mg/0.451
mg and Levomefolate Calcium Tablets, 0.451 mg
Copy of the Company Response for the Apr 11, 2012 - Apr 23, 2012 (13 days) inspection of Memorial Hospital Of South
Bend, IRB located at South Bend / United States of America] 615 N Michigan St, South Bend, IN 46601, USA. This inspection
pertains to Human drugs
Copy of the EIR for the Mar 14, 2011 - Mar 21, 2011 (8 days) inspection of Essex Institutional Review Board, Inc located at
Lebanon / United States of America] 121 Main St, Lebanon, NJ 08833, USA. This inspection pertains to Human Drugs.
Seeking FDA inspection records for the Blood Bank at Northside Hospital in Atlanta, GA from August 2018.
We are seeking all case records associated with the submissions for the following adverse reactions to Rituximab Hycela
reported to the FAERS database between January 1 2017 and present: nervous system disorders (22 cases); gait disturbance
(1 case); vision blurred (2 cases); vision impairment (2 cases); and vertigo (1 case).
Guidance for Industry. Bioanalytical Method Validation FDA, 2001
Internal documentation relating to the marketing denial that we received on Sept 15, 2021
list of certified interstate shellfish shippers
Human Drugs inspection of Belport Co Inc. dba Gingi-Pak ending 11/12/2021 at the location in Camarillo CA, United States.
Please send documents as email attachments.
Animal Drugs & Feeds inspection of Alcami Carolinas Corporation ending 10/29/2021 at the location in Charleston SC,
United States. ETC
1. Communications between the FDA and Johnson & Johnson or Vogue International about reports of injuries, including hair
loss, associated with personal care products (such as OGX shampoo) containing DMDM. 2. Communications between the
FDA and Johnson & Johnson or Vogue International about DMDM hydantoin and/or removing DMDM from personal care
products, including shampoos and conditioners.
1. Communications between the FDA and Unilever or Conopco concerning DMDM hydantoin in personal care products
(such as shampoos and conditioners). 2. Communications between the FDA and consumers or Unilever or Conopco about
people reporting injuries after using Tresemme containing DMDM. 3. Communications between the FDA and Unilever or
Conopco about removing DMDM from personal care products.
Copies of Form 483s issued by the CDER Office
Copies of Form 483s issued to the following DEVICE companies from October 1-31, 2021.
Copies of Form 483s issued to the following DRUG companies from October 1-31, 2021.
I am formally requesting company name, contact name, contact address, and phone number for all businesses/companies
registered as manufacturers of cosmetics, beverages, dietary supplements, pet supplements, nutraceuticals, and food in the
United States.
Any documents related to PolarityTE, Inc.’s drug “SkinTE”, including any trial data, as well as any communications between
the FDA and PolarityTE.
Please provide any new records (dated June 1, 2020 to the present) relating to Edge Pharma, LLC, formerly known as Edge
Pharmacy Services, LLC, an outsourcing facility located at 856 Hercules Drive, Colchester, Vermont.
Human Drugs inspection of B. Braun Medical Inc. ending 11/05/2021 at the location in Daytona Beach FL, United States.
Human Drugs inspection of Carlsbad Technology, Inc ending 11/05/2021 at the location in Carlsbad CA, United States.
for Human Drugs inspection of Pace Analytical Life Sciences, LLC ending 02/07/2018 at the location in Oakdale MN, United
States. Please send documents as email attachments.
Dear Sir or Madam: Under the provisions of the Freedom of Information Act, 5 U.S.C. 552, we are requesting copies of the
following documents pertaining to Food Contact Notification (“FCN”) No. 1745: 1) FCN submission documents for FCN
1745; and, 2) FDA reviews for the FCN 1745. No copies of study data are being requested; therefore, FIFRA Section 10 (g)
does not apply and no affirmation of multinational status will need to be filed. I hereby authorize the expenditure of no
more than $250 to obtain the requested documents. If the cost is expected to exceed the aforementioned amount, please
contact me for further authorizations. If you have any questions about the aforementioned request, please contact me
either by email at wmccombie@pnwpesticideconsulting.com or by telephone at 703-924-0330. Thank you in advance for
your help. Sincerely, Wendy A. McCombie
Documents pertaining to NDA 208524 (Belqiv(R); lorcaserin; specifically Module 2 and Module 4. Module 2: Section 2.4.1
(Overview of Nonclinical Testing); Section 2.4.4., Section 2.6.3, and Section 2.6.6. Module 4: Section 4.1 (Table of Contents),
Section 4.2.3.2 (Repeat Dose Toxicity)
Greenleaf Health is requesting a copy of the Multi-Discipline Review for the approval of Cyltezo (adalimumab-adbm), a
biosimilar of Humira (adalimumab). The review document is for the 10/15/2021 supplemental approval of Cyltezo.
The Establishment Inspection Report (in electronic format) for Biologics inspection of BPC Plasma, Inc., (formerly Biotest
Pharmaceuticals, Corp.) ending 04/08/2019 at the location 2501 Discovery Drive, Suite 400 Orlando, FL United States and
the EIR for the inspection ending 03/28/2019 at the location 311 N. Patterson Street, Valdosta, GA 31601. Please send
Records of product inspection or analysis done by FDA before shipment release at the port of entry or storage facility. Type
of Product: Stevia Sweetener Country of Origin: Bolivia Name of Importer: Luis F. Covarrubias Importer No.: 229-13-8724
Port Code: 5206 (Miami, Florida) Dates of Entry and Air Way Bill #: 05/17/17 BL or AWB: 90190330391 08/07/17 ETC
Request for EIR for LGM Pharma, Irvine Ca., FEI#3017140477
Center for Drug Evaluation and Research non-clinical reviews, including carcinogenicity study summaries, for the following
approved New Drug Applications (NDAs): • 210795 • 209627 • 212327 • 212273
I need original NADA 120-161 of the product ANTIROBE Capsules.
This is a Freedom of Information Act (FOIA) request for import data relating to of Entries ES6-7001673-3, WD8-0062264-5,
KM6-1550034-5, and KM6-1555698-2.
NDA 077510
[Reference FGI# 21-76152] Relevant to 75F40121C00011 we specifically request copies of the following agency records: (1)
Contract, with applicable SOW/PWS, Labor rates/categories and all Task/Delivery Orders
[Reference FGI# 21-76153] Relevant to HHSF223201710016I we specifically request copies of the following agency records:
(1) Contract, with applicable SOW/PWS, Labor rates/categories and all Task/Delivery Orders
Medical Devices & Rad Health inspection of Invotec International Inc. ending 11/04/2021 at the location in Jacksonville FL,
United States. Please send documents as email attachments.
Medical Devices & Rad Health inspection of Spinal Balance, Inc. ending 10/29/2021 at the location in Swanton OH, United
Medical Devices & Rad Health inspection of Surmodics Inc ending 11/04/2021 at the location in Eden Prairie MN, United
Human Drugs inspection of Regeneron Pharmaceuticals Inc ending 10/25/2021 at the location in Rensselaer NY, United
States. The 483 (in electronic format) for Human Drugs inspection of Unither Manufacturing LLC. ending 10/15/2021 at the
location in Rochester NY, United States. Please send documents as email attachments.
Medical Devices & Rad Health inspection of AmericanBio Inc. ending 11/04/2021 at the location in Canton MA, United
States. The 483 (in electronic format) for Medical Devices & Rad Health inspection of Synapse Dental ending 11/01/2021 at
the location in Cranston RI, United States. Please send documents as email attachments.
Foods & Cosmetics inspection of ANS Nutrition, Inc. (formerly DNE Nutraceuticals, Inc.) ending 09/04/2020 at the location in
Farmingdale NJ, United States. The Response (in electronic format) for Foods & Cosmetics inspection of ANS Nutrition, Inc.
(formerly DNE Nutraceuticals, Inc.) ending 09/04/2020 at the location in Farmingdale NJ, United States. Please send
• All internal and external communications and analyses relating to: (1) FDA’s request for a label strength as approved in
efficacy supplement S-054, (2) FDA’s subsequent determination that the label strength as approved was in error, and (3)
FDA’s agreement of April 16, 2021 with the Reference Product Sponsor for Forteo®. ETC
Documents in the custody of FDA employee Keith Austin containing the words: "McKinsey" AND "opioid" OR
"HHSF223201010014B"
Copy of the 483 for the Feb 10, 2012 - Feb 29, 2012 (20 days) inspection of Endogastric Solutions, Inc. located at Redwood
City / United States of America] 555 Twin Dolphin Dr #650, Redwood City, CA 94065, USA. This inspection pertains to
Medical Devices
Copy of the EIR for the Apr 4, 2011 - Apr 20, 2011 (17 days) inspection of Covenant HealthCare IRB located at Saginaw /
United States of America] 700 Cooper Ave, Saginaw, MI 48602, USA. This inspection pertains to Human Drugs.
all FDA internal documents, internal emails, and safety information regarding Low erucic acid rapeseed oil (Synonyms:
canola oil) in relation to 21 CFR 184.1555 in your files and copies of the Agency’s correspondence relating to this material
Hello, Den-Mat Holdings, LLC would like to request a copy of our 510k letter for K872510, however we are unable to attain
a copy online, nor is it available for download from the 510k database • 510k letter for K872510
EIR from last inspection on 09/06/2018 for Northside Hospital Blood Bank in Atlanta, GA
Date Range: 11/30/2020 - 11/30-2021; searching CVM's ADE database for adverse events in US associated with imidacloprid
+ moxidectin topical solution in all species
we are requesting FSVP import data for L.A Vegetable. We want to know who's using our duns number and is listing us as
their importer.
searching CVM's ADE database for adverse events in US associated with Previcox (firicoxib oral tablets for dogs) in all species
searching CVM's ADE database for adverse events in US associated with enrofloxacin oral tablets in all species.
searching CVM's ADE database for adverse events in US associated with methimazole oral tablets (Felimazole) in all species
for date range.
We request the Agency to provide the CMC (Chemistry, Manufacturing and Controls) sections and invitro characterization
section for the ANDA 209358: Calcitonin Salmon Injection USP, 200 IU/mL held by PAR Sterile Products.
Human Drugs inspection of Plastikon Healthcare LLC ending 11/04/2021 at the location in Lawrence KS, United States.
Foods & Cosmetics inspection of ANS Nutrition, Inc. (formerly DNE Nutraceuticals, Inc.) ending 04/24/2018 at the location in
Farmingdale NJ, United States. etc
Human Drugs inspection of RLC Labs Inc. ending 11/04/2021 at the location in Phoenix AZ, United States. Please send
A complete response letter (CRL) was issued to Braeburn Inc. on December 15th 2021 due to “manufacturing deficiencies”,
concerning the approval of Brixadi, their long-acting buprenorphine depot injection (in-licensed from Camurus) I would like
to have access to the “483 observations” documented by the FDA inspectors during the pre-approval manufacturing site
inspection of Pharmaceutics International Inc. (PII). I expect the inspection(s) to have happened between June 26th 2021
and December 15th 2021 at PII manufacturing sites: 10819 Gilroy Rd Hunt Valley, MD 21031-8213 and 103 Beaver Ct,
Cockeysville, MD 21030-2106. However I don’t want to limit the search to these manufacturing sites alone. A previous CRL
was issued to Braeburn because of Brixadi “manufacturing deficiencies” on the December 2nd 2020. In that case PII was
the manufacturer and “483 observations” were requested. Based on those documents the inspection dates were:
10/19/2020 – 10/30/2020 for the Cockeysville and Hunt Valley sites. The investigator who signed off the “483 observations”
was Junho Pak and the FEI number for both site inspections are: 3006503102 and 1000513101. Perhaps this information will
assist in the new document search.
We request the information specified below for all applications, both funded and unfunded, for_x000D_
Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR)_x000D_
grants, cooperative agreements, and contracts (corresponding to National Institutes of Health_x000D_
(NIH) activity codes R41-42, SB1, U43-44, UT1-2, UB1, and N43-44) submitted to the Food_x000D_
and Drug Administration from 1983 to the present.
483 issued to Daiichi Sankyo Chemical Pharma (Onahama Plant), Iwaki, Fukushima, Japan on FDA inspection. FEI:
3002808054
483 issued to Daiichi Sankyo Chemical Pharma (Tatebayashi Plant,), Gunma, Japan on FDA inspection. FEI: 3012477651
Electronic listing (preferably csv format) of all inspections conducted by FDA since July 2021. The list should cover all FDA
centers and include each FDA inspection ID number, DUNS number and reason for inspection.
Human Drugs inspection of Geneva Laboratories, Inc ending 07/23/2021 at the location in Elkhorn WI, United States. Please
Medical Devices & Rad Health inspection of Greiner Bio-One North America, Inc. ending 10/29/2021 at the location in
Monroe NC, United States. Please send documents as email attachments.
Medical Devices & Rad Health inspection of Medtronic Xomed, Inc. ending 10/29/2021 at the location in Minneapolis MN,
Medical Devices & Rad Health inspection of Namsa ending 09/21/2021 at the location in Minneapolis MN, United States.
Foods & Cosmetics inspection of Universal Preserv-A-Chem Inc. ending 07/22/2021 at the location in Mebane NC, United
All documents related to the CMC (Chemistry, Manufacturing, and Controls) for the ANDA# 065049 (Clindacin-P), originally
approved on May 25, 2000 by USFDA.
Copy of the 483 for the Feb 10, 2020 - Feb 19, 2020 (10 days) inspection of Wintac Limited [Nelamangala Town / India] 300
Franklin Square Dr, Somerset, NJ 08873, USA. This inspection pertains to human drugs.
We request a copy of the Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) regarding its
supplemental new drug application (sNDA) for Cortrophin® Gel given to ANI Pharmaceuticals.
Copy of the disclosable portions of the 483 for the 10/15/2021 inspection of Berkshire Sterile Manufacturing, located in Lee,
MA. Please note this inspection pertained to human drugs.
Hi, I am an investment professional for an asset management firm and would like to request the manufacturing review
package for Wegovy (NDA 215256)? Or if easier, could you please provide the full review package from the approval? Thank
you.
I am an investment professional for an asset management firm and would like to request all 483s issued to Catalent Belgium
SA, FEI number 3007647000, from 1/1/21-12/17/21. Thank you.
Pursuant to the Freedom of Information Act (“FOIA”), 5 U.S.C. §552; and 21 C.F.R. §§20, et seq., we request access to, and
copies of, the March 19, 2020 meeting minutes that the FDA sent to ChemoCentryx on April 14, 2020 pertaining to
ChemoCentryx’s drug avacopan (formerly CCX168 and now TAVNEOS).
Request to provide the Summary basis of approval (SBOA) for Nicardipine Hydrochloride Capsules 20 mg and 30 mg, ANDA
#074928 of Epic Pharma Inc and CARDENE (Nicardipine Hydrochloride) Capsules 20 mg and 30 mg, NDA #019488 of CHIESI
USA INC
Request you to kindly share a copy of the 10 observations issued to Alembic Pharma Ltd after the inspection of its Karkahadi
Plant from oct 28 to nov 10 2021.
All correspondence, inspection reports, violation reports, certifications and all registrations for: Amerisal Food LLC and
Amerisal Import Export LLC 16152 Covello Street Van Nuys, CA 91406 and also prior addresses: 16153 Covello Street, Van
Nuys, CA 91406 and 14233 Halldale Avenue, Gardena, CA 90249 Thank you. David L. Hoffman, Esq. (attorney for Amerisal)
SBA- Wegovy (Semaglutide Injection) - NDA215256. Novo Nordisk.
Any and all records related to BBV152 also know as Covaxin the whole virion vaccine developed by Bharat Biotech. Any
records relating to Ocugen and their involvement with the vaccine in any capacity.
VAERS Report
Current Package insert and labels of RLD, PROTAMINE SULFATE held by ELI LILLY AND CO (Application No. N006460).
Currently, RLD is in discontinued status. We need the currently approved RLD package insert, container and carton label to
develop the generic product.
I would like to see the AE reports for the following branded drugs: Crysvita, Spinraza, Evrysdi, Oxbryta, Arikayce, Ingrezza,
Nuplazid, Lupkynis, Orladeyo, Onpattro, Givlaari, Oxlumo, Orgovyx, Myfembree, Nurtec, Wakix, Epidiolex, Tyvaso, Tepezza,
Tavneos. Thank you!
Summary Basis for Approval (SBA) for pafolacianine (Cytalux, On Target Laboratories, LLC) an imaging agent for use in
ovarian cancer patients to help identify malignant lesions during surgery. NDA approved on 29 November 2021.
I request the recent FDA Form 483 issued to the Catalent fill / finish site in Brussels, Belgium. Our understanding is that this
form 483 was issued to Catalent in late 2021 and that’s what we are requesting. The site address is: Rue Font St Landry, 10
Parc Mercator B-1120, Neder Over Hembeek, Belgium
Please could you supply us with the pre-approval inspection records for the Novartis drug Inclisiran (brand name Leqvio),
ahead of its PDUFA date of 01-Jan-22, from the facility in Schatenau in Austria. If these records are not available because
the inspection hasn’t taken place, please let us know why the inspection is still outstanding or of any other recent issues
with the facility that have been highlighted in the FDA inspection records
Please provide the results for the following CV/Resumes James K Rice, Shymetris M Allen, etc
2016-8151, 2021-6400, 2021-7367, 2021-7453, 2021-7459.
2021-7497, 2021-7498, 2021-7564, 2021-7689, 2021-7748.
Mirror Request 2021-6686
2021-7751, 2021-7814, 2021-7898, 2021-7901, 2021-7970.
2021-8071, 2021-8135, 2021-8143, 2021-8150, 2021-8163.
Any and all correspondence, including responses and subsequent correspondence, relating to warning letters to Honest
Globe, Inc. (dated March 15, 2021; MARCS-CMS 597177) and BioLyte Laboratories, LLC (dated March 18, 2021; MARCS-CMS
603584).
I request copies of any agency documentation or communication with Catalent Belgium SA regarding the FDA Warning
Letter issued to their facility located at Font St Landry 10, 1120 Bruxelles, Belgium concerning vaccines as well as WEGOVY-
semaglutide injection, solution since December 1, 2021 through present day.
ANDA 211546 TENTATIVE APPROVAL LETTER
Request for Efgartigimod Summary basis of Approval for Myathania Gravis ( Including Subject matter reviews and
administrative - correspondance documentation)
U.S. Food and Drug Administration: Psychopharmacologic Drugs Advisory Committee Meeting (transcript), Rockville, Md,
FDA, 2006. http://www.fda.gov/ohrms/dockets/ac/cder06.html
Dear Officer: Under the Freedom of Information Act, 5 U.S.C. subsection 552, I am requesting access to the Form 483 letter
given to the Catalent facility in Brussels, Belgium (DUNS 370696762 / FEI 3007647000) related to manufacturing of drug
products.
I am searching for 483s or Warning Letters that were issued to Catalent, specifically at their Catalent Belgium Site. The
associated product area is drugs. Could you please provide any 483s or Warning Letters related to Catalent Belgium? Thank
you very much.
Please provide the latest approved package insert and patient insert of MONUROL® (fosfomycin tromethamine) Granules
for Oral Solution (NDA # 050717).
Biologics inspection of Labcorp Bedford LLC. ending 09/14/2021 at the location in Bedford MA, United States. Please send
Human Drugs inspection of AMPLIFY BIO ending 08/05/2021 at the location in West Jefferson OH, United States. Please
Requesting any Form 483s for Catalent Belgium SA, a CMO facility producing fill/finish of human drugs (including Wegovy) in
Brussels, Belgium at the following address: Rue Font St Landry 10 Parc Mercator B-1120 Neder Over Hembeek, Belgium
Human Drugs inspection of Hydrox Chemical Company Inc ending 06/24/2021 at the location in Elgin IL, United States. The
EIR (in electronic format) for Human Drugs inspection of Hydrox Chemical Company Inc ending 06/24/2021 at the location in
Elgin IL, United States. etc
Copy of the disclosable portions of the 483 for the 11/8/2021 - 11/30/2021 inspection of Catalent, located in Chelsea, MA.
Please also send any 483s issued to Catalent's Brussels, Belgium facility, from 10/01/2021 - Present. Please note that the
scope of these inspections would be human drugs.
Copy of the disclosable portions of the Tentative Approval Letter for ANDA 211546 (amphetamine aspartate, amphetamine
sulfate, dextroamphetamine saccarate, dextroamphentamine sulfate), by SpecGx, dated 06/27/2019.
Requesting the following document in electronic PDF format: The 483 for the inspection of Catalent Massachusetts, LLC (FEI
number 3011696115) ending 11/30/2021 at the location in Chelsea, MA, United States.
We are requesting the CMC and pharmacology Summary Basis of Approval for ELAVIL (Amitriptyline Hydrochloride Tablets
10 mg,25 mg,50 mg,75 mg,100 mg and150 mg held by ASTRAZENECA PHARMACEUTICALS LP. NDA 012703
A copy of each Form FDA 3542 submitted by Amarin Pharma Inc. for the listing of patent information in FDA’s Orange Book
for NDA 202057 for Vascepa (icosapent ethyl) Capsules, 500 mg and 1 GM, for the following patents: 10576054, 10668042,
10786478, 10792267, 10792270, 10842766, 10842768, 10881632, 10894028, 11000499, 11103477, 11116742 and
11154526.
We are requesting the CMC and pharmacology Summary Basis of Approval for ZIAC (Bisoprolol Fumarate
&Hydrochlorothiazide Tablets) 2.5 mg/6.25 mg,5.0 mg/6.25 mg and 10 mg/ 6.25 mg held by TEVA. NDA 020186
full-length case reports (including full narratives) for all adverse events related to poppy seeds resulting in overdose,
dependence, death, or any other serious or medically important outcome reported to FDA between January 2019 and
December 2021
Summary basis of approval and Medical Review for Vyvgart (Efgartimod) in Myasthenia Gravis
Copy of the 483 for the Sep 17, 2012 - Sep 28, 2012 (12 days) inspection of Bernard H. Doft, M.D. located at Pittsburgh /
United States of America] 3501 Forbes Ave #500, Pittsburgh, PA 15213, USA. This inspection pertains to Human Drugs.
Copy of the Company Response for the Sep 17, 2012 - Sep 28, 2012 (12 days) inspection of Bernard H. Doft, M.D. located at
Pittsburgh / United States of America] 3501 Forbes Ave #500, Pittsburgh, PA 15213, USA. This inspection pertains to Human
Drugs.
Copy of the EIR for the Sep 17, 2012 - Sep 28, 2012 (12 days) inspection of Bernard H. Doft, M.D. located at Pittsburgh /
United States of America] 3501 Forbes Ave #500, Pittsburgh, PA 15213, USA. This inspection pertains to Human Drugs.
Copy of the FDA response only to the following file numbers: 2019-832 2019-9070 2021-4516 2019-3383 2021-4579
Copy of the FDA response only to the following file numbers: 2020-5856, 2021-1463, 2021-4375, 2021-7986, 2019-11747.
Copy of the FDA response only to the following file numbers: 2020-6364 2021-4004 2020-3662 2021-3980 2020-7715
Biologics inspection of David Miklos, MD ending 07/27/2017 at the location in Palo Alto CA, United States. Please send
Human Drugs inspection of David Miklos, MD ending 04/07/2017 at the location in Palo Alto CA, United States. Please send
Human Drugs inspection of Cangene BioPharma LLC ending 04/16/2021 at the location in Baltimore MD, United States. The
Response (in electronic format) for Human Drugs inspection of Cangene BioPharma LLC ending 04/16/2021 at the location
in Baltimore MD, United States. Please send documents as email attachments.
Human Drugs inspection of Janssen Cilag Manufacturing LLC ending 11/23/2021 at the location in Gurabo PR, United States.
The EIR (in electronic format) for Human Drugs inspection of Janssen Cilag Manufacturing LLC ending 11/23/2021 at the
location in Gurabo PR, United States. The Response (in electronic format) for Human Drugs inspection of Janssen Cilag
Manufacturing LLC ending 11/23/2021 at the location in Gurabo PR, United States. Please send documents as email
attachments.
Pursuant to the Freedom of Information Act (FOIA), 5 USC 552, and Food and Drug Administration (FDA) implementing
regulations at 21 CFR Part 20, I am writing to request the drug approval package (commonly referred to as the “review
documents”) and action package for new drug application (NDA) 215395, for Lanreotide injection, held by InvaGen
Pharmaceuticals, approved on December 17, 2021.
I am writing to request the Detail Reports for antiarrhythmics (list of Active Pharmaceutical Ingredients provided below)
from January 1st, 2005 to January 1st, 2021. Adenosine Amiodarone Atenolol Bisoprolol carvedilol Digoxin Diltiazem
Disopyramide dofetilide dronedarone esmolol Flecainide ibutilide Lidocaine Magnesium Sulfate Metoprolol Mexiletine
nebivolol Phenytoin Procainamide Propafenone Propranolol Quinidine Sotalol Timolol Verapamil
most recent Establishment Inspection Report for Bloodworks Northwest's Eugene Oregon collection and distribution site.
We are looking for and FAERS reports that have been submitted for Pegcetacoplan
Requesting for one electronic copy of US-FDA approval letter for “ALBUTEROL SULFATE”, ANDA# 074880.
2020-8880, 2020-2549, 2020-1496, 2020-1883, 2019-6101, 2019-5864, 2017-6001
Copy of the 483 for the Jan 14, 2020 - Jan 22, 2020 inspection of American Fertility Medical Center, Genetic Infertility &
Andrology Lab, 2 Hughes STE 175,Irvine, CA 92618, USA. This inspection pertains to biologics.
Copy of the 483 for the Nov 12, 2019 - Nov 21, 2019 inspection of EUCYT Laboratories LLC, 5670 S Wynn Rd Ste D, Las
Vegas, NV 89103, USA. This inspection pertains to biologics.
Copy of the 483 for the Oct 15, 2019 - Oct 22, 2019 inspection of Shriram Institute for Industrial Research, University
Road ,University Enclave, Delhi, 110007, India. This inspection pertains to human drugs.
Copy of the 483 for the Oct 21, 2019 - Nov 1, 2019 inspection of Centurion Medical Products Corporation, 100 Centurion
Way, Williamston, MI 48895, USA. This inspection pertains to medical devices.
File Number 2017-8405
Long range safety and efficacy of "High Frucrose Corn Syrups"
Would like records of all entries where Amy's Kitchen, Inc and Amy's Kitchen Inc located in CA, ID, and OR were listed as the
FSVP Importer.
Please provide Citizen Petition , Docket No. 1984-P-0086 along with its approval letter for the product THEO-DUR
(THEOPHYLLINE) TABLET, EXTENDED RELEASE ORAL 100MG,300MG for the Applicant SCHERING CORP-085328
All customs data for any entries that list Wegmans Food Markets, Inc. as the FSVP importer during the requested time
period. Please include derivations such as Wegmans, Wegman's, Wegman, Wegmans Warehouse, and Wegmans Grocery
Human Drugs inspection of Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company ending 07/12/2021 at the location
in Manati PR, United States. The EIR (in electronic format) for Human Drugs inspection of Caribe Holdings (Cayman) Co. Ltd
dba PuraCap Caribe ending 07/02/2021 at the location in Dorado PR, United States. Please send documents as email
attachments.
Foods & Cosmetics inspection of Fernandez Development Co. ending 09/16/2021 at the location in Chatsworth CA, United
States. The EIR (in electronic format) for Foods & Cosmetics inspection of Fernandez Development Co. ending 09/16/2021
at the location in Chatsworth CA, United States. The Response (in electronic format) for Foods & Cosmetics inspection of
Fernandez Development Co. ending 09/16/2021 at the location in Chatsworth CA, United States. Please send documents as
email attachments.
Please provide Summary Basis of Approval of ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ORAL 10mg, 25mg,50mg
and 100mg for the Applicant PFIZER INC- N010392
2021-7097, 2021-7118, 2021-7124, 2021-7141, 2021-7153.
2021-7164, 2021-7165, 2021-7232, 2021-7269, 2021-7288.
2021-7290, 2021-7292, 2021-7296, 2021-7297, 2021-7298.
2021-7299, 2021-7300, 2021-7302, 2021-7425, 2021-7452.
Active Ingredient: SODIUMPHOSPHATE,DIBASIC,HEPTAHYDRATE; SODIUMPHOSPHATE,MONOBASIC,ANHYDROUS

Proprietary Name: SODIUMPHOSPHATESIN PLASTICCONTAINER Dosage Form; Route of administration: INJECTABLE;
INJECTION Strength: 142MG/ML;276MG/ML Reference Listed Drug: Yes Reference Standard: Yes TE Code: -
Application Number: N018892 Product Number: 001 Approval Date: May 10, 1983 Applicant Holder Full Name:
HOSPIRA INC Marketing Status: Prescription
Alkem Laboratories Limited Baddi, Solan, India End Dates of inspection: 21 February 2020 Project Area: Drug Quality
Assurance District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request,
however please contact me if the charges exceed $ 200.
4/2/21 tentative approval letter for ANDA No. 212953 for Fingolimod (generic drug) etc
Aurobindo Pharma Ltd. Bachupally, India End Dates of inspection: 21 February 2020 Project Area: Drug Quality Assurance
District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request, however please
contact me if the charges exceed $ 200.
Citagenix Inc. Bachupally, India End Dates of inspection: 21 February 2020 Project Area: Drug Quality Assurance District
Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request, however please contact
me if the charges exceed $ 200.
The following two (2) CSV files: 1) Listing of all INSPECTIONS since Friday, January 1, 2021 (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 Friday, January 1, 2021 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
All records provided for control #2020-6396
I write to request copies of previously produced documents, communications, and information from the FDA’s Center for
Drug Evaluation and Research (“CDER”), Center for Biologics Evaluation and Research (“CBER”), and the Office for
Regulatory Affairs (“ORA”) concerning the inspection of facilities owned and/or operated by Catalent Pharma Solutions
(“Catalent”) that are located at 10381 Decatur Road, Philadelphia, Pennsylvania 19154.
Regulatory Affairs (“ORA”) that concern the inspection of facilities owned and/or operated by AGC Biologics, Inc. (“AGC
Biologics”) in Denmark, including its facilities located at Vandtårnsvej 83, 2860 Søborg, Denmark.
Regulatory Affairs (“ORA”) that concern the inspection of facilities owned and/or operated by Patheon Manufacturing
Services, LLC, part of Thermo Fisher Scientific (“Patheon”), including its facilities located at 5900 M.L.K. Jr Hwy, Greenville,
North Carolina 27834 and at Via Stucchi G. Battista 110, 20052 Monza, Italy (MI).
Regulatory Affairs (“ORA”) that concern the inspection of facilities owned and/or operated by the Lonza Group AG (“Lonza”)
located at 228 Bath Rd, Slough SL1 4DX, United Kingdom.
All records and response letters provided for FOIA request 2019-184
The appeals log or spreadsheet record showing appeals logged by FDA FOIA department in the months of November 2021
responsive records from: 2018-8950.
WARNING LETTER
The approval letters for the following abbreviated new drug applications (ANDA) for the drug entacapone (Comtan): ANDA
078941 ANDA 203437 ANDA 205792 ANDA 206669 ANDA 090690 The approval letters for the following ANDAs for the drug
carbidopa; entacapone; levodopa (Stalevo): ANDA 079085
All response letters and records provided for FOIA requests, 2020-5, 2020-865, 2020-6501, 2020-8007
Placebo controlled trial with Quetiapine (Seroquel) in elderly demested patients with behavioral disorders. I am specifically
looking for the trials that lead to Seroquel receiving a black box warning in 2005.
I am looking for Establishment Inspection Reports (EIRs), Form 483s, and Form 482s from Catalent's sites in Woodstock, IL,
Bloomington, IN, Morrisville, NC, and Brussels, Belgium.
PREVIOUSLY RELEASED RECORDS
All reports of adverse events and/or side effects for Vimpat (aka lacosamide)
I am requesting a employee email contact list in Excel Spreadsheet format for all FDA employees to be sent by email
Food Contact Notifications (FCN) 1478, 1753 and 1927.
483 issued to Macleods Pharmaceuticals Limited, Baddi, District Solan, India
Human Drugs inspection of John Heymach, M.D ending 11/05/2021 at the location in Houston TX, United States. Please
Human Drugs inspection of Catalent Massachusetts, LLC ending 11/30/2021 at the location in Chelsea MA, United States.
The EIR (in electronic format) for Human Drugs inspection of Catalent Massachusetts, LLC ending 11/30/2021 at the location
in Chelsea MA, United States. ETC
Foods & Cosmetics inspection of Natures Health Options, LLC ending 09/28/2021 at the location in Boca Raton FL, United
States. The EIR (in electronic format) for Foods & Cosmetics inspection of Natures Health Options, LLC ending 09/28/2021
at the location in Boca Raton FL, United States. ETC
Human Drugs inspection of KBI Biopharma, Inc. ending 03/06/2020 at the location in Boulder CO, United States. The
Response (in electronic format) for Human Drugs inspection of KBI Biopharma, Inc. ending 03/06/2020 at the location in
Boulder CO, United States.
Information on the NDA submission date by sponsor Applied Therapeutics for a drug listed as (potentially) AT-007 for
galactosemia or Classic Galactosemia (CG). Other important information would be helpful but the date of completed NDA
submission is the key request.
Investigational New Drug (IND) submission granted to Cassava Sciences Inc. for Simufilam in 2017.
Please provide disclosable, redacted 483s, 483 Responses, and EIRs in electronic format (.pdf) that have been released since
Tuesday, November 30, 2021.
DOCUMENTS AVAILABLE TO ASSIST RELEASED PRISONERS
DEUTSCHE KASE HAUS, MIDDLEBURY, IN - INSPECTIONS, TESTING, AUDITS, ETC
CVs for Ana Paula P Sandee, Marilyn S Babu, Keegan B Mixon, Jon P Antoniou, Laurie Nelson, etc
2016-8474, 2016-8527, 2016-8579, 2016-8676, 2016-8696.
2021-5515, 2016-8329, 2016-8424, 2016-8425, 2016-8473.
2021-6042, 2021-6416, 2021-6406, 2021-6785, 2021-6841.
2021-6944, 2021-6957, 2021-7029, 2021-7052, 2021-7094.
2021 Listeria monocytogenes outbreak stemming from Dole Packaged Salad
2021 Listeria monocytogenes outbreak stemming from Fresh Express_x000D_
Packaged Salad
We request all entry-line records that contain any of the following data points in reference to an entry’s FSVP Importer,
Importer of Record (IOR), or Consignee; for entry-lines with submission or arrival dates between December 1 and December
31, 2021: 1) DUNS Number / Unique Facility Identifier (UFI) of: 080801169 2) Federal Tax ID Number (EIN) of: 822349285
etc
ALL FORM 483 BY/FOR MONARCH PCM, LLC LOCATED AT 7333 JACK NEWELL BLVD. NORTH SUITE 100 FORTH WORTH, TX
76118
Any readily information available about the NDA application number 050537
Original request and responsive material to log # 2018-1476
Produce documents sufficient to identify the total number of doses of Comirnaty (COVID-19 Vaccine mRNA) administered
within the United States of America following full FDA approval of Comirnaty (COVID-19 Vaccine mRNA). Please note that
this request does not seek and protected health information of any recipients of the product but is merely seeking the total
number of doses administered following approval on August 23, 2021.
This is the same request we submit for quarterly. C.H. Robinson Worldwide, Inc. requests a spreadsheet which includes the
23 publicly available data points for all FSVP importer declarations.
Product registration documentation and all subsequent supplements for ANDA060730 as per the attached request letter.
Hello, I would like to request all of the Adverse Medical Reports made (online or via mail or any other method) by or about
Ideal Breast Implants, Mentor Breast Implants, Sientra Breast Implants, Inamed Breast Implants, and Allergen Breast
Implants from 2000 to the present that are not available on MAUDE, containing the following: -responsible manufacturer
name -adverse event date -patient problem -device problem etc
HR RECS RE GRUBER, KRAUSE
U.S. Food and Drug Administration: Briefing Document for Psychopharmacologic Drugs Advisory Committee, December 13,
2006, http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006–4272b1–01-FDA.pdf [fda.gov]
INDIVDIUAL RECS
INDIVIDUAL RECS
We would like to request a copy of the package insert for the discontinued Brand product, CELESTONE (Betamethasone
Sodium Phosphate injection).
This is a request under the Freedom of Information Act. I request that a copy of documents concerning the following
subject matter be provided to me: an electronic spreadsheet (not PDF, please) of Voluntary Cosmetic Registration Program
(VCRP) data, including VCRP category frequency of use totals, ingredient and category totals of frequency of use data, as
well as just ingredient frequency of use totals, as has been provided in recent years.
All documents, records, correspondence, or any other material provided in response to FOIA Request 2020-3721
Hi, We would like to FOIA the review documents for Fyarro
a copy of all tests that prove that receiving any of the Covid-19 vaccines will help prevent severe illness in individuals
For each Vaccine Manufactured by Pfizer Inc. during the referenced period of time, please release the following
information: 1. All active pharmaceutical ingredients 2. All non-active pharmaceutical ingredients
For each study supported by BioNTech and Pfizer, please provide the following: 1. The most current publicly accessible
link 2. The most current number of deaths broken down by category
When can a non-medically licensed individual without a prescription and without any documented medical need: 1.
Contain proof of using a substance which has the phrase “Rx only” on the packaging label?
Documents reflecting any documented case of an individual who: (1) never received a COVID-19 vaccine; (2) was infected
with COVID-19 once, recovered, and then later became infected again; and (3) died due to SARS-CoV-2.
In accordance with Freedom of Information Act procedures, GRAS Associates, LLC requests information related to GRAS
Notices 162, 174, 189, 191, and 235. Specifically, we request any additional information to that provided on the GRAS
Notice Inventory, such as meeting minutes or email correspondence within CFSAN.
Foods & Cosmetics inspection of United Pharma LLC ending 04/02/2021 at the location in Fullerton CA, United States.
Medical Devices & Rad Health inspection of Euclid Systems Corporation ending 02/21/2019 at the location in Sterling VA,
for Biologics inspection of Packaging Coordinators, LLC ending 12/18/2020 at the location in Philadelphia PA, United States.
Human Drugs inspection of SK Life Science Inc. ending 08/11/2021 at the location in Paramus NJ, United States. The EIR (in
electronic format) for Human Drugs inspection of SK Life Science Inc. ending 08/11/2021 at the location in Paramus NJ,
Foods & Cosmetics inspection of Taylor Farms California Inc ending 02/14/2018 at the location in Yuma AZ, United States.
The EIR (in electronic format) for Foods & Cosmetics inspection of Taylor Farms California Inc ending 02/14/2018 at the
location in Yuma AZ, United States. The Response (in electronic format) for Foods & Cosmetics inspection of Taylor Farms
California Inc ending 02/14/2018 at the location in Yuma AZ, United States. Please send documents as email attachments.
I need the 483 and EIR for BPI Sports, located in Fort Lauderdale, Florida 33312-6802 performed on 5/17/2017. The FEI is
3011842031. Previous request showed no records. Current EIR noted this inspection. Inspection was VAI. Thank you,
Courtland
I would hereby like to request the following document through FOIA. o Drug product approval package for Kayexalate
(Sodium Polystyrene Sulfonate) Powder Oral/Rectal, NDA # N011287 o Any documents available regarding the review and
approval of this product by the FDA such as Review Package, Approval Letter, Clinical Pharmacology review, Summary basis
of Approval
Investigation of Hinkle Fine Foods; 4800 Wadsworth Rd; Dayton, OH 45414.
Hi I am completing a research project looking at osteonecrosis of the jaw associated with anti-TNF medications. The case ID
numbers I am requesting are as follows: 10567324 9980820 9245746 9239649 9193642 9049003 8572469 8257208
7971195 7687578 7372426
I'm requesting access to and copies of the following: - The EIR issued in response to the inspection conducted of Valisure
LLC that ended on July 6, 2021. Valisure is located at 5 Science Park, New Haven, CT, 06511. A Form 483 was issued that
cited six observations.
Any and all audits or inspections conducted at Kite Pharma, Inc. located at either of the following address: 2355 Utah Ave.,
El Segundo, CA 90245 OR 2383 Utah Ave., El Segundo, CA 90245
NICHOLS INSTITUTE 483 ETC
Any and all communications (this can include email, text messages, twitter direct messages, any agency intranet, agency
forum communications or bulletins, Microsoft TEAMs, etc.) between the following people from January 1, 2020 until
January 5, 2022. Anthony Fauci Francis Collins Ron Klain Deborah Birx Gregg Gonsalves Cliff Lane Lawrence Tabak Janet
Woodcock Rick Bright Dr. Rochelle P. Walensky etc
copies of, preliminary comments that the FDA sent to ChemoCentryx on October 26, 2016 pertaining to ChemoCentryx’s
drug avacopan (formerly CCX168 and now TAVNEOS).
On behalf of Lupin Pharmaceuticals, Inc. I request you to provide me with the labeling for BUMEX (NDA 018226) owned by
Validus Pharms approved on 10/29/2002 (Suppl-25).
Form 483 and any other related inspection records for Catalent Belgium SA, FEI number: 3007647000. Firm address: Font
Saint-Landry 10, Brussels, Brussels-Capital Region 1120, Belgium.
FSVP SPREADSHEET
Chemistry & Toxicology Review Memos for FCN 1393
Copy of the 483 for the Apr 12, 2021 - Apr 20, 2021 (9 days) inspection of Emergent Manufacturing Operations Baltimore
LLC [Baltimore / United States of America] 5901 E Lombard St, Baltimore, MD 21202, USA. This inspection pertains to
biologics.
Copy of the 483 for the Apr 5, 2021 - Apr 16, 2021 (12 days) inspection of SURGENEX LLC [- / -] 15444 N 76th St #110,
Scottsdale, AZ 85260, USA. This inspection pertains to biologics.
Copy of the 483 for the Feb 23, 2021 - Apr 30, 2021 (67 days) inspection of Smiths Medical ASD Inc. [Plymouth / United
States of America] 6000 Nathan Ln N, Plymouth, MN 55442, USA. This inspection pertains to medical devices.
Copy of the 483 for the May 25, 2021 - Jun 24, 2021 (31 days) inspection of Invacare Corporation [Elyria / United States of
America] 1 Invacare Way, Elyria, OH 44035, USA. This inspection pertains to medical devices.
Copy of the FDA response only to the following file numbers: 2019-9070 2021-4516 2019-3383 2021-4579
Electronic listing (preferably csv format) of all RRAs conducted since October 1, 2021
Enforcement Reports
I request copies of all documents in the possession of FDA, from October 1, 2021 to December 31, 2021, regarding products
sold under the brand name: “Jamieson” including any: a) Form FDA 3500 Voluntary Reporting, b) Form FDA 3500B Voluntary
Reporting for Consumer and, c) Form FDA 3500A Mandatory Reporting.
We request a spreadsheet which includes the 23 publicly available data points for all entries that led to the inclusion of all
TJX Brands - HomeGoods, HomeSense, Marshalls, Sierra, TJ Maxx, on FDA's list.
We request a spreadsheet which includes the 23 publicly available data points for all entries that led to the inclusion of the
following companies in this list in 2019: Nestle USA, Inc (DUNS number 00-825-6224), Nestle Professional (DUNS number
07-678-0409), Dreyer's Grand Ice Cream Holdings, Inc. (DUNS number 06-656-3859), Nestle Puerto Rico (DUNS number 09-
014-5707), ETC
We request a spreadsheet which includes the 23 publicly available data points for all entries that led to the inclusion of the
companies listed in the attached document.
We request a spreadsheet identifying the firms that received FDA Warning Letters between October 1, 2011, and January 1,
2022 or the most recently available date
Under FOIA, I request all text messages sent and received by Sean Duke (FDA-ORA) between November 1, 2021-December
31, 2021.
Under FOIA, I request all text messages sent and received by Sean Duke (FDA-ORA) between November 1, 2021-December
31, 2021.
Please could I have a copy of the source documents and the MedWatch form for FAERS case number 19620185, which is a
case report of Angioedema and Anaphylactic Reaction associated with BTG product CroFab.
Meitheal Pharmaceuticals request the most recently submitted carton label for the 4mcg/2mL (2mcg/mL) strength of NDA
021027 Hectorol (doxercalciferol injection). The label will be used for comparison against our ANDA therapeutic equivalent
to ensure it is updated to date and aligned with the RLD. Please send the label via electronic email as we are working
remotely due to COVID. Thank you,
test request
I am writing to request copies of all documents produced by the Food and Drug Administration in response to a previous
request pursuant to Freedom of Information Act number 2021-8203 concerning pharmaceutical manufacturers Laboratorios
Farmacéuticos ROVI, S.A. and ROVI Pharma Industrial Services sites in San Sebastián de los Reyes and Madrid, Spain
Please could I have a copy of the MedWatch form and any available source documentation for AERS report 17920987,
which is a case report associated with BTG product Voraxaze. Thank-you
Pursuant to the Freedom of Information Act, 5 U.S.C. §552; and 21 C.F.R. §§20, et seq., we request access to, and copies of,
minutes of the October 5, 2016 meeting between the FDA and Reata Pharmaceuticals, Inc. pertaining to Reata’s drug
bardoxolone methyl.
1) All Form 483 issued to Pharmaceutics International, Inc. for its facility in Cockeysville, Maryland. Between 2015 and
2018. 2) All letters, emails and other communications between the FDA and Pharmaceutics International, Inc. for its facility
in Cockeysville, Maryland 2015 and 2018.
I am trying to track down a copy of the "Emerging oncology drug targets in the 21st century: An FDA analysis." presentation
(see the link below) that was presented by FDA employees (Emma C. Scott, Yutao Gong, Ashim Subedee, Dickran Kazandjian,
Richard Pazdur, V. Ashutosh Rao, Julia A. Beaver, Julie A. Schneider) at the 2020 ASCO Annual Meeting.
https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.e14067
Inspection reports from all on-site inspections conducted as part of the E.Coli outbreak investigations with reference
numbers 5, 7, E-441626, 1010 and 1043.
Copy of FOIA request submitted by William Dickinson on October 8, 2021, for "all documents, including but not limited to
correspondence and/or inter-departmental investigations related to the billing practices of Natera, Inc., Invitae Corp. and
Myriad Genetics, Corp. between September 30, 2018 to September 30, 2021," and a copy of all documents provided in
response to this FOIA request.
510(k) - K173119
2021-5397, 2016-8093, 2016-8136, 2016-8141, 2016-8147
Copy of the disclosable portions of the original request letter and complete FDA response for File Number 2019-10157
EIR report for inspection conducted on 6/11/2021 at Sterling Technology, Inc. Location address is 133 32nd Ave S.
Brookings, South Dakota.
EIR, Hospira Pfizer, Mcpherson Kansas from April 16, 2010
EIR, Hospira Pfizer, Mcpherson Kansas plant, from February 18, 2018
EIR, Hospira Pfizer, Mcpherson Kansas from January 4, 2012
Hi, I would like to request the Form 483 issued, and the Company Response to, the June 23, 2021 manufacturing facility
inspection of Professional Disposables International, Inc. located in Orangeburg, NY. Thank you!
Human adverse event drug MedWatch reports for the following Case IDS: 16175245 16580464 15588199 15608982
15609317 15686978 14029588 14074197 14800116 14914381 14914500 14927962
I'm looking to receive a copy of the meeting minutes from the FDA's recent Type A meeting with Revance Therapeutics, Inc.
related to the company's DaxibotulinumtoxinA for injection product. The meeting was held in December 2021 or January
2022.
FCN 2104
Please provide Summary Basis of Approval of DEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION 80MG/ML for
the Applicant PFIZER INC-N011757
Biologics inspection of Bio-Rad Laboratories, Inc. ending 12/13/2021 at the location in Woodinville WA, United States.
Biologics inspection of Predictable Surgical Technologies ending 11/18/2021 at the location in Hebron KY, United States.
Biologics inspection of Reproductive Health Specialists, Inc. ending 12/08/2021 at the location in Pittsburgh PA, United
Biologics inspection of Zhang Medical P.C. d/b/a New Hope Fertility Center ending 11/30/2021 at the location in New York
NY, United States. Please send documents as email attachments.
Human Drugs inspection of Ausberto B. Hidalgo, M.D. ending 12/03/2021 at the location in Pembroke Pines FL, United
Human Drugs inspection of Eastman Chemical Company ending 12/01/2021 at the location in Kingsport TN, United States.
Human Drugs inspection of Edge Pharmacy Services, LLC ending 11/30/2021 at the location in Colchester VT, United States.
2016-8152, 2016-8233, 2016-8318, 2016-8324, 2016-8421.
2016-8476, 2016-8603, 2016-8608, 2016-8707, 2016-8738.
2016-8751, 2016-8771, 2021-6401, 2021-6784, 2021-7362.
Request for records that have led to Schnuck Markets, Inc (also listed as below names) to be listed on the FDA Importer
September, 4 2021 thru December, 16 2021. SCHNUCK MARKETS INC SCHNUCK MARKETS, INC. SCHNUCKS MARKETS INC-
ST LOUIS -NORTH PARK DRY SCHNUCKS MARKETS INC TOPCO
Requesting the following document in electronic PDF format: I am requesting access to all 483 letters given to the Catalent
facility in Brussels, Belgium (which may be for Catalent Belgium SA, FEI 3007647000) in 2021.
EIR, Hospira Pfizer Mcpherson Kansas plant, from April 3, 2015
EIR, Hospira Pfizer, Mcpherson Kansas from August 16, 2013
EIR, Hospira Pfizer, Mcpherson Kansas from August 27, 2009
EIR, Hospira Pfizer, Mcpherson Kansas from May 25, 2011
EIR, Hospira Pfizer, Mcpherson Kansas from October 24, 2012
EIR, Hospira Pfizer, Mcpherson Kansas plant, from August 15, 2018
EIR, Hospira Pfizer, Mcpherson Kansas plant, from January 17, 2020
EIR, Hospira Pfizer, Mcpherson Kansas plant, from June 8, 2016
EIR, Hospira Pfizer, Mcpherson Kansas plant, from October 27, 2017
Dear Sirs. I am an investment professional research analyst for an equity research firm and would like to request all 483s
issued to Catalent Belgium SA, FEI number 3007647000, from 1/1/21-12/17/21.
We would like to request case reports / case narratives for drug Galafold.
All documents, directives, and correspondences pertaining to goods La Squisita Food Corp. imported under Entry/CDP-FDA
814-0247864-8/11-1, especially with respect to FDA hold notices, orders of fumigation or other such directives requiring La
Squisita to take any action with respect to these goods. Also seeking any documents or explanations elaborating on the FDA
line status was, "May Proceed Without FDA Examination," on 2/1/2017 for these goods, as indicated on the the FDA ITACS
page for Entry/CDP-FDA 814-0247864-8/11-1. I am enclosing a copy of this report under the "request letter" optional
attachment for ease of reference.
I am seeking information on a baby consumer product made by Munchkin, Inc. (based in California).
Any FDA-483 forms pertaining to Medical Devices for the following FDA registered establishment: "Viewray Incorporated"
Registration Number 3011233554 located in Mountain View, CA
Foods & Cosmetics inspection of Bactolac Pharmaceutical, Inc. ending 11/19/2021 at the location in Hauppauge NY, United
Foods & Cosmetics inspection of Nutracap Labs LLC ending 12/06/2021 at the location in Norcross GA, United States. Please
Medical Devices & Rad Health inspection of B&W Tek, Inc. ending 12/08/2021 at the location in Newark DE, United States.
Medical Devices & Rad Health inspection of Katecho Inc ending 12/02/2021 at the location in Des Moines IA, United States.
Medical Devices & Rad Health inspection of Ultrasonic Services, Inc. ending 12/10/2021 at the location in Houston TX,
Summary Basis of Approval information for NDA 212854: ZIMHI NALOXONE HYDROCHLORIDE 5MG/0.5ML
(5MG/0.5ML), approved October 15, 2021
Copies of all documents and information regarding Bluebird Bio, Inc., previously released by the FDA pursuant to a FOIA
request, from 2015 to the present.
Under terms of the Freedom of Information Act, I'm kindly requesting Inspection Records, Observations, Reports and
responses relating to the inspection of FUJIFILM DIOSYNTH BIOTECHNOLOGIES, 100 DISCOVERY DRIVE, SUITE 200 COLLEGE
STATION, TX 77845, FDA ESTABLISHMENT NUMBER 301198449. Inspection period August 23-31, 2021.
Various records
2021-8210 2021-8307 2021-4898 2021-3636 2020-7739 2020-8485 2019-8016
The approval letter and approved label (including prescribing information,_x000D_

patient leaflet and instructions for use) for ANDA 213948._x000D_
At the url https://www.access.fda.gov/itacs/app/welcomeToITACS.jsf , FDA provides information about the status of

customs entries. We would like to receive a daily excel spreadsheet of all ITACS shipment entries containing two columns:
entry number and FEI number.
Copy of the 483 for the Mar 1, 2021 - Mar 5, 2021 (5 days) inspection of Durisan [Sarasota / United States of America] 7810
25th Ct E #106, Sarasota, FL 34243, USA. This inspection pertains to human drugs.
FAERS Case Number 19230671, for Zepatier
Cosmetic Solutions LLC, 6101 Park of Commerce Blvd, Boca Raton, FL, 33487; Requesting any FDA visit reports, or any
records of 482, 483
We request all documents pertaining to FCN 1835. These documents may include but are necessarily limited to the
notification itself and correspondence (deficiency and response letters and emails) with the notifier, any amendments to
the notification, and any information developed by FDA regarding the notification such as summary memos.
Please provide a copy of the container and carton labeling for the discontinued injectable product cupric sulfate (EQ 0.4MG
copper/mL) having NDA #019350 previously marketed by ABRAXIS PHARMACEUTICAL PRODUCTS.
All records and response letters provided for FOIA request 2019-209
Documents or documents containing the following information regarding the substance (Deferoxamine mesylate, CAS: 138-
14-7, trade name e.g.: Desferal®): • Pre-natal developmental toxicity study cited in Label for NDA 016267 Desferal®,
Novartis, 12/16/2011: o “Delayed ossification in mice and skeletal anomalies in rabbits were observed after Desferal was
administered in daily doses up to 4.5 times the maximum daily human dose. etc
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 from approximately September 4, 2017 - December 3 2017.
Request you to kindly share a copy of the observations in the warning letter issued against Aurobindo Pharma Ltd.'s, India
API facility at Hyderabad. The inspection that took place between Aug 2 to Aug 12 2021 and an OAI was issued in
November.
Recent warning letter issued to Aurobindo Pharma Limited following August 2021 inspection of the company's Unit 1 API
manufacturing facility in Hyderabad, India.
To whom it may concern, We would like to see the inspection outcome regarding the 482 we received on Dec.02, 2021.
The inspection was conducted by Patricia Alberto. at 4480 Gundry Ave. Long Beach, CA, 90807. Thank you, Melody
following two documents from NDA 215256 approved on 4, June 2021 for the product Wegovy. The second document is
referenced in the NDA. 1. Clinical Review Summary 2. dConrad, A. Proprietary Name Review for (b)(4) (IND 126360). Silver
Spring (MD): FDA, CDER, OSE, DMEPA (US); 2020 Oct 19. Panorama No. 2020-39466751.
COVID VACCINE QUESTIONS
Medical Devices & Rad Health inspection of ARP Wave L.L.C. ending 12/06/2021 at the location in Apple Valley MN, United
I am requesting a digital copy of inspection results for an FDA inspection conducted on 24 February 2020 at Sterigenics, Los
Angeles, 4900 Gifford Ave, Vernon, CA. Inspection was conducted by Sarah Hassas. Inspection results were emailed to the
General Manager at the time, Alan Suppiphatvong, on 23 April 2020.
2021-5971 2021-6291 2021-7126 2021-7723 2021-7919 2021-7989 2021-7990 2021-8083 2021-8094 2021-8364 2021-
8523
I'd like to request an adverse report for Opzelura in PDF and Excel from Jan 2021-2022.
I am requesting a copy of the most current Investigator Drug Brochure for the Pfizer BNT162B2 (PF-07302048)
vaccine._x000D_
_x000D_
Thank you,_x000D_
_x000D_
Sharla Winters
EUA for comirnaty 12-15 covid vaccine. When will the vaccine expected to be fully approved by the FDA for 12-15. Study
submitted from Phizer or others regarding vaccine for 12-15 to the FDA and CDC for approval.
1) A definition of COVID-19 etc
Summary Based Approval Package pertaining to the Bioequivalence (BE) discipline review for ANDA 205742, Glycerol
Phenylbutyrate Oral Liquid, 1.1 g/mL held by Par Pharmaceutical Inc.
Summary Based Approval Package pertaining to the Bioequivalence (BE) discipline review for ANDA 209452, Sapropterin
Dihydrochloride Oral Powder, 100 mg/packet held by Dr. Reddys Laboratories Ltd.
Summary Based Approval Package pertaining to the Bioequivalence (BE) discipline review for ANDA 210027, Sapropterin
Dihydrochloride Oral Powder, 500 mg/packet held by Par Pharmaceutical Inc.
I'd like to request an adverse report for Ayvakit in PDF and Excel from Jan 2021-2022.
Food warehousing and distribution of CHEESE and CREAM All records (inspection reports and correspondence) for: GSUS
EMPIRE (or GSUS)(owned by David & Elfy Gomez) 9901 San Fernando Road, Pacoima, CA 91331 (unit #31)
FAERS Public Dashboard case id:10684766 Please provide the case details for this Dysport (Botulinum Toxin Type A) safety
report.
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 from approximately September 4, 2021 - December 16,
2021.
The most current FDA CDER Designated Medical Event (DME) list used in adverse event monitoring and signalling. The DME
list for Human drugs (used by Center for Drug Evaluation and Research (CDER) office of surveillance and epidemiology)
copies of, the November 1, 2016 meeting minutes that the FDA sent to ChemoCentryx on November 14, 2016 pertaining to
ChemoCentryx’s drug avacopan (formerly CCX168 and now TAVNEOS).
483 Response from Teva Parenteral Manufacturing in Irvine California on August 20, 2021
483 Response from Teva Parenteral Manufacturing in Irvine California on July 29, 2016
483 from Teva Parenteral Manufacturing in Irvine California on August 20, 2021
483 from Teva Parenteral Manufacturing in Irvine California on August 30, 2019
483 from Teva Parenteral Manufacturing in Irvine California on January 18, 2019
483 from Teva Parenteral Manufacturing in Irvine California on July 29, 2016
483 from Teva Parenteral Manufacturing in Irvine California on May 14, 2010
483 issued to Catalent Pharmaceuticals, Brussels, Belgium, from Nov. 1, 2021, to Dec. 31, 2021.
EIRs from Fresenius Kabi in Grand Island, New York on February 25, 2000
EIRs from Teva Parenteral Manufacturing in Irvine California for all inspections from July 1, 2021 to September 1, 2021
EIRs from Teva Parenteral Manufacturing in Irvine California on April 24, 2012
EIRs from Teva Parenteral Manufacturing in Irvine California on August 30, 2019
EIRs from Teva Parenteral Manufacturing in Irvine California on May 14, 2010
Please provide narrative case reports for the attached 11 FAERS case
I'd like to request the adverse event reports for Fintepla (fenfluramine) by Zogenix in PDF and Excel.
We kindly request all information on the D-psicose (allulose) GRAS submission from Blue California, filed as GRN 1024,
including the notice, any communications with the notifier before or since the notice was submitted, and any other internal
FDA communications such as memorandum regarding the notice or any pre-submission consultations.
2020-8149, 2021-6434, 2021-6851, 2021-7080, 2021-7125.
I'd like to request the full case reports of Fintepla (fenfluramine) by Zogenix in PDF and Excel for 19581582, 19601131,
19601125, 18255254, 18647457, 19606337, 18770182 and 19845826. If possible, please email the findings directly to
quinn.lin@point72.com. Thank you!
2021-5623, 2016-10506, 2020-6975, 2020-6976, 2020-7861.
2021-7205, 2021-7327, 2021-7356, 2021-7368, 2021-7370.
2021-7413, 2021-7702, 2021-7725, 2021-7838, 2021-7900.
We are a group of researchers from the finance department at University of Oregon. We are working on a project
measuring the financial consequences of product recalls. We request to have Enforcement Weekly Report(Recall Report)
starting from 2000. We would like the content to be as complete as possible.
NDA 008845
Foods & Cosmetics inspection of Taylor Farms Northwest, LLC ending 08/08/2016 at the location in Kent WA, United States.
The EIR (in electronic format) for Foods & Cosmetics inspection of Taylor Farms Northwest, LLC ending 08/08/2016 at the
location in Kent WA, United States. The Response (in electronic format) for Foods & Cosmetics inspection of Taylor Farms
Northwest, LLC ending 08/08/2016 at the location in Kent WA, United States. Please send documents as email attachments.
I would like to request the Establishment Inspection Report from the most recent inspection at the Memphis, Swinnea Rd.
facility, registration number 3009380063. This inspection started on 16-Nov-2021 and concluded on 18-Nov-2021. .
All DEATH adverse event related to all polyethylene glycol 3350 products for pediatric and adult use 1970 to present.
Requesting detailed report, not summary. Thank you.
All adverse events for all polyethylene glycol 3350 products for adult and pediatric use, including all voluntary and
mandatory reports from 1970 to present. Requesting detailed report, not summary. Received wrong dates for this recently.
Please see dates 1970 to present. Thank you very much.
Records of entries in which Harris Teeter LLC or similar variations of such name is listed as the FSVP importer.
Please provide Original approval letter for ANDA 210362 approved on 06-19-2018.
21CFR 178.3260 says that I can get a copy of the "Journal of the Association of Official Agricultural Chemists" Volume 45
February 1962 , article "A More Sensitive and Selective Ultraviolet Absorption Criterion for Mineral Oil" from CFSAN (HFS-
200). I would like a copy please.
Copy of the 483 for the Sep 16, 2019 - Sep 20, 2019 (5 days) inspection of Conformis Inc. [Wilmington / United States of
America] 600 Research Dr, Wilmington, MA 01887, USA. This inspection pertains to medical devices.
Responsive documents to log # 2008-7042
ICSR report (case 20198414)
Requesting an electronic copy in PDF format of the most recent approved prescribing information, including images of the
product carton and container labeling, for NDA 019350, Cupric Sulfate EQ 0.4mg copper/mL, Injectable; Injection. As per
Drugs@FDA, the most recent approved labeling was from June 9, 1992, however the label is not available on the website.
Can I please request for all Establishment Inspection Reports since January of 2020 at Catalent Brussels, Belgium. Can I also
please request the 483 letter from January of 2020 for Catalent. Thank you,
I'm requesting access to and copies of the following: - Records released in response to the previously released FOIA request
#s (including the original request): 2020-1451, 2021-5433, 2021-7312, 2021-7510, 2021-7511, 2021-7876, 2021-7983, 2021-
8017, 2021-8018, 2021-8019, 2021-8106, 2021-8221, 2021-8269, 2021-8639, 2021-8732
Hello, I am cordially requesting all documents related to FAERS case IDs: 19274808 18731898 18738641 19158684
19318485
for Biologics inspection of Bio-Rad Laboratories, Inc. ending 12/13/2021 at the location in Woodinville WA, United States.
Please provide all FDA Office of Criminal Investigations cases related to 2,4-Dinitrophenol that resulted in conviction from
2017 to current date. Example: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/
press-releases/texas-woman-sentenced-6-months-federal-prison-selling-deadly-weight-loss-drug-consumers
We are looking for a Summary Basis of Approval (SBOA) for the drug product OPZELURA (ruxolitinib) cream, 1.5% (NDA
215309) which was approved on 09/21/2021. We request you to provide us the SBOA of all disciplines (CMC, CLINICAL,
NON CLINICAL etc.)
Conflict of interest materials including real or potential conflicts pertaining to Sara Rothman (Sara.Rothman@fda.hhs.gov).
Freedom of Information Act (FOIA) request for records regarding: Package Insert and primary container labeling for the
below referenced product: Active Ingredient: ERIBULIN MESYLATE Proprietary Name:HALAVEN etc
Information on entries for which an FSVP importer is identified with "Whole Foods," "Whole Food," "Wholefoods," or
"Wholefood" as part of it's name, whether or not capitalized, to include manufacturer's name and address, filer's name and
address, arrival date, entry number, port of entry, country of origin, product description, and final admissibility.
interested in documents related to control numbers: 2021-7416 2021-7689 2021-7784 2021-7990 2021-8221 2021-8459
2021-8523 2021-8640 2021-8672 2021-8776
Documents pertaining to covid vaccines containing graphene oxide
We request a copy of all Summary Basis of Approval documents for NDA 213436 for Trudhesa nasal spray by Impel
Neuropharma.
FCN 1558
NDA 202107 Please provide a copy of the following: January 27, 2017, DMPP review by Sharon Williams (concurrence from
team leader Shawna Hutchins and from Meena Ramachandra of OPDP). _x000D_
Human adverse event drug MedWatch reports for the following Case IDs: 12581349 12620152 12971086 12971110
12980840 13052535 13143464 13387928 13441020 13578893 13603479 13787042
Full set of FOIA requests submitted to FDA since January 1995, including (1) a control number that uniquely identifies each
FOIA request, (2) the day on which the request was received by the FDA, (3) the date on which the FDA response is due, etc
All cancer treatments and cures that have been denied an FDA safety approval
Request for a list of inspections conducted by FDA pursuant to the Prescription Drug Marketing Act (PDMA) from 2018 to
present.
Human Drugs inspection of Genzyme Corporation ending 10/20/2008 at the location in Cambridge MA, United States.
All records released under FOIA 2021-7730
Records indicating the date on which the Clinical Pharmacology Biopharmaceutics Review for Biologics License Application
125276 for Actemra (tocilizumab) Injection (approved on January 8, 2010) was made publicly available on the Drugs@FDA
portion of FDA's website
Recs re inspection of facilities owned and/or operated by Lonza Group AG (“Lonza”) and located at either 14905 Kirby Drive,
Houston, Texas 77047 or 101 International Drive, Portsmouth, New Hampshire 03801. .
Any documents, contracts, or messaging_x000D_

regarding the Razer Zephyr or Razer Zephyr Pro facemasks (or their previous_x000D_
codename, Project Hazel) and N95 or other NIOSH standard labeling for its filters
complaints related to the RAZER ZEPHYR_x000D_

brand mask from Jan. 5 to the date records for this request are produced. I am also_x000D_
requesting any applications for NIOSH approval as an N-95 respirator for the same_x000D_
mask, and any responses or correspondences from the CDC about that certification
Our project group needs the monthly Orange Book data for year 2017, please.
The FDA Letter of No Objection dated December 21, 2021 issued to Revolution Company for their polymer Linear low
density polyethylene (LLDPE).
Summary basis of approval for cisplatin NDA 018057
ANDA 213948 12/13/2021 Approval Letter FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE please email to:
michele.crawley@cipla.com
Kindly please provide copies of the following FAERS ID cases: 19626819, 19510441, 19301250, 19086481, 19086480,
19086469
Under the Freedom of Information Act as amended, please provide all records previously disclosed regarding the 1982
Tylenol poisoning cases in Chicago.
Full set of FOIA requests submitted to FDA since January 1995, including (1) a control number that uniquely identifies each
FOIA request; (2) requester’s identity (both person and company); (3) record date; (4) close date; (5) target firm or
individual; (6) outcome of the request; (7) a short description of which agency records were requested; (8) the FDA offices
and the divisions to which the request is pertinent
Status
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Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Partial Denial
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
No Record(s)
Closed
Closed
Closed
Closed
Closed
No Record(s)
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed

Closed
No Record(s)
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
No Record(s)
No Record(s)
Closed
Duplicate Request
Referral (Outside FDA)
Closed
No Record(s)
No Record(s)
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
No Record(s)
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
No Record(s)
Closed
Closed
Closed
Closed
Duplicate Request
Closed
Closed
Closed
Closed
Closed
No Record(s)
Closed
Closed
Closed
Closed
Closed

Closed
Closed
Closed
Closed
Closed
Closed

Closed
Closed
No Record(s)
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
No Record(s)
Closed
Closed
Closed
Closed
Closed
Closed

Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed

Closed
Closed
Closed
No Record(s)
Closed
Closed
Closed

Closed
No Record(s)
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
No Record(s)
Closed Denial
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Referral (Outside FDA)
Closed
Closed
Closed
Closed

Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed

FDA FOIA Closed Log Jan 2022

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FDA FOIA Closed Log Jan 2022

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