FDA FOIA Closed Log - January 2020 - 0

Control # From Subject
Requesting all inspection records and 483s for Restore Robotics. Locations include Atlanta, GA,
2020-974 JPMC Anaheim, CA, Panama City, FL.
2020-972 Amol Soin RECORDS RE WARNING LETTER
Form FDA 483: Arc3 Gases Statesville, NC End Dates of inspection: 05 September 2019 FDA District
2020-962 Thomson Reuters - Clarivate Analytics Office: Atlanta District District Decision: VAI
I'm requesting access to and copies of the following: - Any and all records, including but not limited to
communications, documents, and or memos, pertaining to the E.coli outbreak involving romaine
2020-967 CONSUMER REPORTS lettuce from Subway sandwich shops, between Nov. 1, 2019 and Dec. 31, 2019.
Form FDA 483: Friendship Industries Inc. Rockingham, VA End Dates of inspection: 26 August 2019
2020-923 Thomson Reuters - Clarivate Analytics FDA District Office: Baltimore District District Decision: VAI
Form FDA 483: C-Care, LLC Linthicum Heights, MD End Dates of inspection: 16 September 2019 FDA
2020-927 Thomson Reuters - Clarivate Analytics District Office: Baltimore District District Decision: VAI
Video recording of the open hearings known as the - FDA Psychopharmacologic Drugs Advisory
2020-950 Benjamin Bathen Hearing PSYCHOPHARMACOLOGIC DRUGS ADVISORY COMMITTEE Monday, December 13, 2006
2020-954 KEVIN RIJS PATTIES FOODS - PKG APRVL 1/18 TO 1/24/20
Form FDA 483: Andrew R. Gould, M.D. Louisville, KY End Dates of inspection: 08 August 2019 FDA
2020-949 Thomson Reuters - Clarivate Analytics District Office: Cincinnati District District Decision: VAI
2020-944 WES PHARMA PACKAGE INSERT AND MEDICATION GUIDE FOR ANDA 040482
Form FDA 483: Toby Orthopaedics, Inc. West Miami, FL End Dates of inspection: 18 September 2019
2020-929 Thomson Reuters - Clarivate Analytics FDA District Office: Detroit District District Decision: VAI
Form FDA 483: IR Techology LLC Acworth, GA End Dates of inspection: 05 September 2019 FDA
2020-921 Thomson Reuters - Clarivate Analytics District Office: Atlanta District District Decision: VAI
Video recording of the open hearings known as the PSYCHOPHARMACOLOGIC DRUGS ADVISORY
COMMITTEE WITH THE PEDIATRIC SUBCOMMITTEE OF THE ANTI-INFECTIVE DRUGS ADVISORY
2020-948 Benjamin Bathen COMMITTEE Monday, February 2, 2004.
The Summary Basis of Approval for the original New Drug Application for HEXALEN (altretamine),
which was approved on 12/26/1990 under NDA 019926, and any related non-confidential
2020-942 Lennham Pharmaceuticals, Inc. correspondence between the sponsor (Eisai) and the Review Division.
Form FDA 483: Custom Healthcare Systems, Inc. Richmond, VA End Dates of inspection: 04
2020-925 Thomson Reuters - Clarivate Analytics September 2019 FDA District Office: Baltimore District District Decision: VAI
2020-961 THE WALL STREET JOURNAL DAVID REDL CALENDAR 11/21/17 TO 5/10/19
Video recording of the open hearings known as the PSYCHOPHARMACOLOGIC DRUGS ADVISORY
2020-947 Benjamin Bathen COMMITTEE Friday, September 20th 1991
Form FDA 483: Medstar Georgetown University Hospital Washington, DC End Dates of inspection: 10
2020-932 Thomson Reuters - Clarivate Analytics September 2019 FDA District Office: Baltimore District District Decision: VAI
2020-938 FOI Services, Inc. TEST
Form FDA 483 : Rockford Specialties Loves Park, IL End Dates of inspection: 10 September 2019 FDA
2020-918 Thomson Reuters - Clarivate Analytics District Office: Chicago
Form FDA 483: Paket Corp Chicago, IL End Dates of inspection: 06 August 2019 FDA District Office:
2020-937 Thomson Reuters - Clarivate Analytics Chicago District District Decision: VAI
Form FDA 483: Octapharma Plasma, Inc. Forestville, MD End Dates of inspection: 23 September 2019
2020-936 Thomson Reuters - Clarivate Analytics FDA District Office: Baltimore District District Decision: VAI
Form FDA 483: Dynofit Inc. Carrollton, TX End Dates of inspection: 18 September 2019 FDA District
2020-924 Thomson Reuters - Clarivate Analytics Office: Dallas District District Decision: VAI
Hikma requests 2017 approval letter for ANDA 206106; additionally requesting information regarding
2020-940 Hikma Pharmaceuticals USA, Inc. basis of submission for ANDA 206106.
Form FDA 483: Liquid Crystal Resources Hallcrest LLC Glenview, IL End Dates of inspection: 01
2020-919 Thomson Reuters - Clarivate Analytics October 2019 FDA District Office: Chicago District District Decision: VAI
Form FDA 483: University of Texas Medical Branch (UTMB) Blood Center Galveston, TX End Dates of
2020-931 Thomson Reuters - Clarivate Analytics inspection: 11 September 2019 FDA District Office: Dallas District District Decision: VAI
2020-951 Americans for Homeopathy Choice HOMEOPATHIC TEETHING PRODUCTS; ACONITUM NAPELLUS; ALLIUM CEPA, ETC - AER
2020-946 Shawn Olsson Promotional pharmaceutical materials filed by Athenex.
Form FDA 483: Tristar Dental Laboratory, Inc Houston, TX End Dates of inspection: 23 July 2019 FDA
2020-930 Thomson Reuters - Clarivate Analytics District Office: Dallas District District Decision: VAI
Biocell Textured Breast Implant Devices manufactured and sold by Allergan, Inc., Allergan USA, Inc.,
Allergan PLC, Inamed Corporation and/or McGhan Medical Corporation APPROVAL RECS, ADVERSE
2020-883 Mazie Slater Katz & Freeman, LLC EVENTS, ETC
2020-895 RAY THOMPSON The FDA-483 document for: Unetixs Vacular, Inc., 125 Commerce Park Rd. North Kingstown, RI 02852
The FDA-483 document for: ARL Biopharma, Inc. dba Analytical Research Labs, 840 Research Pkwy,
2020-901 RAY THOMPSON Ste 546, Oklahoma City, OK 73104
2020-876 COVINGTON & BURLING LLP 2019-10472
2020-859 NATURAL PRODUCTS ASSOCIATION questions re requested scientific studies on CBD
2020-905 Ninas Mexican Foods records of any FDA Inspections made at Ninas Mexican Foods Inc in Walnut CA 91789
The FDA-483 document for: Hangzhou Lenkeweier Daily Chemicals Co., Ltd. Maoshantou Village,
2020-864 RAY THOMPSON Yiqiao, 568 Dongfang Road, Xiaosha, Hangzhou, India
2020-898 RAY THOMPSON The FDA-483 document for: Radix Laboratories, Inc. 1334 International Dr., Eau Claire, WI 54701
2020-866 Alain Martin 1972 original approval package for MARCAINE (NDA 01696) - summary basis of approval .
2020-858 Investec Capital Services India Pvt Ltd Inspection classification questions
2020-871 Major Pharmaceuticals Establishment Inspection Report for Pharmatech, located in Davie Florida.
2020-874 Daniel Graver IMPORT DATA
483 from inspection of Teva API India Ltd. facility in Malanpur, Bhind District, India, taking place
2020-868 PAR Pharmaceutical around April 2019.
Any and all documents, relating or pertaining to Entry B9G-00116840, including but not limited to the
2020-848 LT Foods Americas bases for FDA refusal of the entry and FDA sampling, test and analytic reports of the entry.
2020-830 Point Seventy Two adverse reports in PDF & Excel for Rybelsus
2020-836 Point Seventy Two adverse reports in PDF & Excel for Rinvoq - ABBV
2020-832 Point Seventy Two adverse reports in PDF & Excel for Oxbryta (Voxelotor) - GBT
Product name: Mupirocin Cream 2% Application number: A201587 Applicant: Glenmark
2020-841 Srinivas Gurram Pharmaceuticals Inc
Clinical trial information about the drug Paludrine. The peak concentration in blood, elimination time,
2020-851 EMORY UNIVERSITY half life, AUC, etc.
2020-834 Point Seventy Two adverse reports in PDF & Excel for Ubrelvy - AGN
2020-853 Dechra Ltd FOI summaries for NADA 043-304 and 045-290 (ketamine hydrochloride).
2020-846 Ford Heilizer AERS for Arazlo owned by Bausch Health Companies Inc.
All records, communications with Philips, text messages, electronic records, phone logs, interviews,
2020-855 Thomas Quinn inspections, comments, and other records for or associated with case number CC156646.
Clinical trial information pertaining to the drug Malarone including the peak blood concentration and
2020-843 EMORY UNIVERSITY other relevant parameters
The 483 (in electronic format) for Biologics inspection of Catalent Indiana, LLC ending 02/24/2012 at
2020-809 FDAZILLA the location in Bloomington IN
2020-815 Step Change Pharma Inc. form 483 issued to Gfm Gesellschaft fur Micronisierung mbh - Bremen, Germany on 11/17/2017
2020-800 JOHNS HOPKINS UNIVERSITY Approval package reviews for Metastron STRONTIUM CHLORIDE SR-89
Drug approval package (FDA approval letter and labeling, FDA application review files) and/or
2020-816 Sun Pharma Global FZE amendments/supplements for Maxidex NDA 013422
Product: Calcitonin Salmon Injection (Miacalcin) NDA # 017808 NDA Holder: Mylan Ireland Ltd
Reviews required: 1. Chemistry review 2. Medical review 3. Pharmacology/Toxicology review
4. Microbiology review 5. Clinical Pharmacology & Biopharmaceutics Reviews 6. Labeling
2020-813 HIKMA FARMACEUTICA (PORTUGAL) LDA Reviews 7. Other reviews
2020-812 General Mills - QRO/FSQ 483 EIR GENERAL MILLS, CARLISLE IA
2020-811 Point Seventy Two adverse reports in PDF & Excel for Wakix - Harmony Biosciences.
Approval Package for supplemental NDA 21-427/s-030, approval letter is appended. Clin Pharm
2020-817 Biohaven Pharmaceuticals Review, Medical Review, and Statistical Review.
2020-824 Amin Talati Wasserman LLP ENTRY B9G-00116840 - FDA REFUSAL, TEST, ANALYTIC RPTS, ETC
2020-822 FALCON RESEARCH ANIKA THERAPEUTICS - CINGAL CLNCL TRIAL RECS
2020-801 Pacifica Beauty LLC. Hello we would like to see analytical report for SAM# 1132819.
minutes from Biogen's Type C meetings with the FDA in June 2019, and on 10-21-19 regarding
2020-821 RBC CAPITAL MARKETS aducanumab
2020-810 Point Seventy Two Vumerity - BIIB. FAERS
Recall History for:PROFILEV MEDTOXScan Drugs of Abuse Test System All Adverse Event Reports
2020-808 Butch Crawford involving the PROFILEV MEDTOXScan Drugs of Abuse Test System
data on how many investigational new drug applications for antisense oligonucleotide drugs intended
2020-814 Erika Check Hayden to treat one patient were received by the Center for Drug Evaluation and Research in 2019.
2020-755 Swiss American CDMO, LLC 483's and warning letters for Emilia Resources located in DeKalb, Mississippi.
inspection records aurobindo pharma unit 7 ,formulation plant s1,survey 411,425,434-
435,458,tsiic,green industrial park,telangana,india i am seeking current plant status post inspection of
2020-781 siddharth karnawat plant ended on 27/09/2019 ,,,,,,, oai ,vai or nai
DETAILED NARRATIVES 6511918, 6573327, 5951554, 10905274, 15368257, 14816457, 6691894,
2020-788 Benjamin Bathen 8726010, 6045005, 6701735
cipla goa plant L129 - 146 S - 1 03 - 1 05 S - 1 07 - 112 L147 - L147 1 ,Vasco Da Gama, Goa, 403 7 22
2020-784 siddharth karnawat India i need current plant status : oai ,vai, or nai post inspection ended on 27/09/2019
2020-795 Dr Ajay Phadke Form 483 for Alembic's Karkhadi API Unit (2 obs) SMS Pharma's API Unit in AP (2 obs)
FDA 483 or inspection OAI record for SEA William P Werschler MD Spokane WA 99204
2020-787 Lisa Freeman US 11/29/17 CDRH Project Evaluation: Devices OAI
2020-779 Therapeutics, Inc. FDA's Summary Basis of Approval (or Drug Approval Package) for NDA 022341 Supplement No. 027
The EIR (in electronic format) for Human Drugs inspection of Novartis Pharmaceuticals Corp. ending
2020-796 FDAZILLA 12/14/2018 at the location in East Hanover NJ, United States. ETC
All 806 reports and associated documents submitted to the FDA regarding actions involving "quality
issues with certain Cardinal Health surgical gowns and packs"
https://www.fda.gov/news-events/press-announcements/statement-quality-issues-certain-cardinal-
2020-789 CBS NEWS health-surgical-gowns-and-packs
2020-783 ET Now 483 for Lupin’s Vizag API facility in India
2020-753 TUTHILL CORPORATION request a copy of FDA laboratory worksheets. entry number 906-0233566-6
FOIA log that contains every FOIA request submitted between the two dates specified that were not
2020-778 Ford Heilizer fulfilled due to exemption 6 or exemption 7(a).
2020-766 Satsuma Pharmaceuticals FDA approval documents relating to the following 3 supplements for NDA 005929 for D.H.E.45
Complete Drug Approval Package for NDA 019655: History, Letters, Labels, Reviews, Administrative
2020-770 AUBURN UNIVERSITY Documents, Correspondence Drug Brand Name: Retrovir (zidovudine) etc
September 20, 1991 - FDA Psychopharmacologic Drugs Advisory Hearing September 13, 2004, - FDA
Psychopharmacologic Drugs Advisory Hearing February 2, 2004 - FDA Psychopharmacologic Drugs
2020-792 Benjamin Bathen Advisory Hearing December 13, 2006 - ETC
2020-790 Tina Brooks INDIVIDUAL RECS
Copies of Form 483s issued by CDER’s International Operations Group to Apollo Health and Beauty
2020-765 FDA NEWS Care, Inc from Aug. 1, 2019 to Dec 31, 2019.
2020-798 Karlynne Ormbrek BREAST IMPLANT RECS
2020-785 Equirus Securities Lupin's Vizag API (FEI 3013127166) plant from Jan 13, 2020 to Jan 17, 2020 Form 483
2020-775 Dr Ajay Phadke Form 483 for Lupin's API facility at Vizag (5 observations) Lupin's Nagpur facility (3 observations)
All 806 reports and associated documents submitted to the FDA regarding actions involving "quality
issues with certain Cardinal Health surgical gowns and packs"
https://www.fda.gov/news-events/press-announcements/statement-quality-issues-certain-cardinal-
2020-780 CBS NEWS health-surgical-gowns-and-packs
DETAILED NARRATIVES • 5892685 • 10745122 • 11892142 • 7341832 • 6879191 •
2020-791 Benjamin Bathen 9636409 • 7186408 • 6526659 • 14422332 • 8762927
Form FDA 483: Advanced Engineering, Inc. Huntington, IN End Dates of inspection: 18 September
2020-777 Thomson Reuters - Clarivate Analytics 2019 FDA
2020-715 Point Seventy Two adverse reports in PDF & Excel for Sunosi - Jazz Pharma.
2020-714 FIRST PRIORITY, INC. FOI for NADA 141-330 - see attached for a letter with the specific requested data
2020-702 CAMIL CONSULTING CORP 2019-3420
EIR for all inspectional activity between the dates of September 2019 to current (January 2020)
Tetiana Nehrych, M.D. Lviv Regional Hospital Department of Neurology, 7 Chernihivska Lviv, 79010
2020-692 Celgene Corporation Ukraine Product Area: Drugs
Center for Pharmaceutical Information and Engineering Research of

2020-710 Peking University 1. Mentholatum (China) Pharmaceuticals Co., Ltd.ZhongshanCN6/21/2019 483 etc
Entry documentation and other records directly related to inclusion of Pamir Gida Sanayi, located in
2020-712 OLSSON FRANK WEEDA TERMAN MATZ PC Istanbul TURKEY, on the Red List for Import Alert 45-02.
2020-748 LIPSITZ AND PONTERIO LLC XELJANZ XR - 15428659, 14922470, 15073514, ECT
2020-736 Strides Pharma science limited Approval letter A062911 - Vancomycin Hydrochloride Injection - Holder Hospira.
copies of all FDA letters to Allakos Inc. which mention AK001. 2. All Allakos Inc. and letters from
2020-691 CAMIL CONSULTING CORP Allakos Inc. to FDA which mention AK001.
17016414 17021640 17067923 17084801 17089194 17093392 17112839 17125644 17135628
2020-707 Pura Vida Investments 17137469 17140758 17142848
2020-693 Amol Soin WARNING LETTER QUESTIONS
2020-751 LEIGH HALSTAD CMPLNTS
483 which was issued to Chugai Pharma Manufacturing, Utsunomiya, Japan by CDER inspection.
2020-737 Office YM Would be dated 9/1/2017 (ym-01)
All documents pertaining to docket entries in Docket No. A-15-103(CTP v. TOH, Inc. d/b/a Ridgeville
Service Center), Docket No. A-19-50 (CTP v. Stowers Enterprises, Inc. d/b/a BP), and Docket No. T-17-
2020-735 Shehadeh Giannamore PLLC 764 (CTP v. Hollistic, Inc. d/b/a 7-Eleven Store 25975A)
2020-727 Office YM 483 which was issued to Eisai Company, Kakamigahara, Japan by CDER inspection. (ym-3)
FULL Video recording of the open hearings known as the JOINT MEETING OF THE CDER
PSYCHOPHARMACOLOGIC DRUGS ADVISORY COMMITTEE AND THE FDA PEDIATRIC ADVISORY
2020-696 Benjamin Bathen COMMITTEE Monday, September 13, 2004 8:00 a.m.
483 which was issued to Chugai Pharmaceutical - Kita, Japan by CDER inspection. Would be dated
2020-743 Office YM 9/27/2017 (ym-2)
Drug Approval Package for New Drug Application (NDA): 019879 (US, Approval 11/28/1990),
Including: Approval Letter(s), Printed Labeling, Medical Review(s), Chemistry Review(s), Pharmacology
Review(s), Statistical Review(s), Microbiology Review(s), Clinical Pharmacology(s), Administrative
2020-741 US WorldMeds, LLC Document(s) and Correspondence(s)
2020-745 MARCY HALEY CMPLNTS 19L00291, 19K00258
2020-705 Orchid Orthopedic Solutions Medical Device Establishment Inspection Reports.

2020-708 Peking University Hangzhou Badi Daily Use Chemical CompanyHuzhouCN3/21/2019 483 etc
sBLA for daratumumab containing the Medical and Statistical reviews for supplement 005. The BLA #
2020-722 Umar Ahmed is 761036 and the supplement # is 005.

2020-711 Peking University 483 forms. 1. Taizhou Kangping Medical Science And Technology Co., Ltd.TaizhouCN etc
2020-747 AKIN GUMP STRAUSS HAUER & FELD LLP CORR BETWEEN FDA & ALLAKOS INC REGARDING AK002 (ANTOLIMAB) 8/1/19 TO PRESENT
Summary basis of information (SBOI)/FOI for Restoril™ (temazepam) Capsules USP, 7.5 mg, 15 mg,
2020-729 Ascend Laboratories LLC 22.5 mg, and 30 mg.
Food and Drug Administration Office of Regulatory Affairs Summary Report Request for Entry# K64-
2020-734 Wismettac Asian Foods Inc. 1060485-9
copies of all documents, including FDA internal memoranda, notes of telecons, minutes of meetings,
inspection reports, etc., related to an FDA Warning Letter to Quest Nutrition, LLC dated July 29, 2015
(WL No. 452841), company response of August 10, 2015 and FDA closeout letter of November 13,
2020-706 Keller and Heckman LLP 2017.
483 Report for any/all inspections for Levothyroxine Sodium for manufacturer Azico Biophore India Pvt
2020-699 PUERTO RICO PHARMACEUTICAL INC Ltd located in India
The Center for Drug Evaluation and Research’s Exclusivity Board memorandum/document reflecting
its decision to grant new chemical entity 5-year exclusivity for Spravato® (esketamine hydrochloride)
2020-694 MORGAN, LEWIS & BOCKIUS Nasal Spray, NDA 211243 (approved March 19, 2019).
inspection reports, establishment inspection reports, warning letter, 483's Best Formulation Inc.
2020-671 LIFE EXTENSION 17775 Rowland Street Cityof Industry, CA 91748
2020-665 Lupin Pharmaceutical FDA approval letter for Diroximel Fumarate by Biogen on Oct 29, 2019.
all documents, including FDA internal memoranda, notes of telecons, minutes of meetings, inspection
reports, etc., related to an FDA Warning Letter to Question Nutrition, LLC dated July 29, 2015 (WL No.
2020-658 Keller and Heckman LLP 452841), company response of August 10, 2015 and FDA closeout letter of November 13, 2017.
copies of any petitions or notifications submitted by Nestle or Glycom pursuant to sections 403(w)(6)
2020-656 Keller and Heckman LLP or 403(w)(7) of the Federal Food, Drug, and Cosmetic Act, 21 USC sections 343(w)(6) and 343(w)(7).
2020-670 Medefil Inc. Succinylcholine Chloride Injection, USP, FDA approved in NDA008845 and NDA008453
2020-687 Zydus Pharmaceuticals USA Inc. DIROXIMEL FUMARATE NDA 211855
2020-662 Bruce C. Ransom Jr. Workforce Relations Division/Division of Employee and Labor Relations emails
2020-690 Satsuma Pharmaceuticals ANDA 078319
2020-680 Dhan AI 2019-11063 2019-11062 2019-11064 2019-11069 2019-8728
A copy of the BLA (Biologics License Application) application for ADUCANUMAB an alzheimer’s drug
2020-683 Ford Heilizer developed by Biogen and Eisai Co.
2020-677 Dhan AI 2019-12052 2019-11886 2019-11884 2019-11879 2019-11668
All pharmacological, ADME and toxicological data submitted by Realm Therapeutics to FDA to proceed
2020-673 Apra International with IND for PR022 for Atopic Dermatitis.
all documents, including FDA internal memoranda, notes of telecons, minutes of meetings, inspection
reports, etc., related to an FDA Warning Letter to Question Nutrition, LLC dated July 29, 2015 (WL No.
2020-658 Keller and Heckman LLP 452841), company response of August 10, 2015 and FDA closeout letter of November 13, 2017.
2020-675 Dhan AI 2019-11666 2019-11664 2019-11367 2019-11363 2019-11211
2020-676 Dhan AI 2019-11875 2019-11448 2019-11449 2019-11447 2019-11667
2020-663 Bruce. C. Ransom Jr. Listing of services offered by the FDA Conflict Prevention and Resolution program.
A copy of the NDA filled by Pfenex Inc for their new drug: JZP-258 which treats Cataplexy and
2020-684 Ford Heilizer Excessive Daytime Sleepiness in Narcolepsy.
Request for final approval letter of Penicillamine, 250 mg tablets approved on December 23, 2019, by
2020-672 Lupin Pharmaceutical Par pharmaceutical.
Copies of Karoun Dairies, Inc 2015 Listeria Outbreak: agency's complete investigation file; genetic
testing information; all requests made to FDA regarding referenced outbreak from inception of the
2020-652 Faegre Baker Daniels LLP agency's investigation to present
FAERS case ID numbers: 16717259, 6821501, 16477295, 16656595, 16469566, 6687881, 6691894,
2020-681 Benjamin Bathen 15545805, 6899800, 5784479
2020-678 Dhan AI 2019-4797 2019-8715 2019-7226 2018-9069 2019-827
Requesting the original Freedom of Information (FOI) for Nicarb 25% (nicarbazin), NADA 009-476. The
FOI should have been submitted within the original new animal drug application submitted sometime
2020-674 Phibro Animal Health Corporation in the 1950's
483 with 5 observations issued by USFDA to Lupin for its Vizag API plant for the inspection conducted
2020-686 Nomura Financial Advisory & Securities (India) Private Limited during January 13, 2020 and January 17, 2020.
FDA Investigative File into La Vang. He was recently convicted in US District Court for the District of
2020-685 KARE-TV Minnesota. Case number 19-cr-97.
2020-679 Dhan AI 2015-7649 2015-7261 2016-2158 2019-11075 2019-11065
Neurological toxicity of immune checkpoint inhibitor (nivolumab, pembrolizumab, atezolizumab,
2020-682 First Affiliated Hospital, Zhejiang University durvalumab, avelumab, cemiplimab, ipilimumab, and tremelimumab)
All submissions by Natural Alternatives International, Inc. ("NAI") for any New Dietary Ingredient
("NDI"), including, without limitation, NDI Notification No 1103, any FDA acknowledgements for any
2020-624 Erica W. Stump, P.A. NAI NDI, and any and all documents related thereto.
2020-646 FOI Services, Inc. 2019-8821
2020-632 COGENCY GLOBAL INC. 2019-11543
2020-651 Point Seventy Two adverse reports in (PDF & Excel) for Onpattro (Patisiran) from Alnylam Pharmaceuticals.
All correspondence to and from the company Allakos Inc., in reference to the their drugs of AK001 and
AK002 which are therapeutic antibody drugs that selectively targets mast cells and eosinophils and
2020-641 CAMIL CONSULTING CORP AK001 and AK002, both of which are monoclonal antibodies targeting Siglec-8.
Any forms 483 issued to the company Natera, Inc, which operates a CLIA certified laboratory in San
2020-634 The Capitol Forum Carlos, California.
Copy of the disclosable portions of all serious adverse event reports for Celsius dietary supplement,
2020-649 soundpost advisory also referred to as Celsius energy drink, Celsius fitness drink, or Celsius Heat drink.
A listing of all FDA Form 483 Notices of Inspectional Observations for: • Pharmaceutical, biologics
and medical device manufacturing facilities, including premarket approval inspections, AND • Clinical
research facilities, investigators and IRBs both in the United States and outside the United States that
2020-643 FDA NEWS received such notices dated from December 1 to 31, 2019.
Review Package or Approval Package of Caplyta, approved on 12/20/2019. Moreover, a

Psychopharmacologic Drugs Advisory Committee Meeting was initially scheduled for Caplyta on
7/31/2019, and was canceled on 7/23/2019 because of new information regarding the application. If
2020-645 Evercore ISI the AdCom meeting materials (slides and summary) are open to public, I'd also want to request them.
2020-630 Dhan AI 2019-11003 2019-11079 2019-12051 2019-12050 2019-12053
2020-625 Michael Maturlak INVESTIGATION RECS
information on all clinical trials (pre-authorization and post-authorization, safety and efficacy)
submitted to FDA from pharmaceutical industry comparing duloxetine with no intervention, placebo
2020-637 Copenhagen Trial Unit or active placebo.
Summary basis of Approval reviews for NDA 019583, Relafen Tablets 500mg, and 750 mg Letters,
Reviews, Labels, and Patient Package Inserts associated with Approvals for Supplement 4, Supplement
2020-636 Zyla Life Sciences US Inc. 5, and Supplement 19 for NDA 019583 Warning Letters associated with NDA 019583
483 (in electronic format) for Human Drugs inspection of Absorption Systems L.P. ending 06/09/2017
2020-598 FDAZILLA at the location in Exton PA etc
2020-605 FDAZILLA 2019-655, 2019-8144, 2019-8786, 2019-9039, 2019-9057
2020-614 AUSTRALIAN LABORATORY SERVICES PTY LTD CAP 7C0308 - COLORCON INC; CAP 3C0298 WM WRIGLEY
2020-622 ROSEMARY RICHARDSON VACCINES; ANTIBIOTIC - AER
VACANCY FDA-00-19-10360656-DH; HHS-FDA-00-17-DH-1873738CA; HHS-FDA-00-17-DH-1928610CA
2020-620 JOSEPH PAUL FINDLER IV RECS
2020-604 FDAZILLA 2019-2961, 2019-3249, 2019-3330, 2019-367, 2019-6259.
2020-602 FDAZILLA 2016-10000, 2017-4370, 2017-6815, 2017-6940, 2017-6981
2020-619 Bernstein Litowitz Berger & Grossmann LLP 2018-9902, 2018-9079, 2019-7975
2020-603 FDAZILLA 2017-7788, 2018-4189, 2018-5675, 2019-10155, 2019-1441.
2020-549 Dhan AI 2017-9832, 2017-9833, 2018-2119, 2018-2391, 2018-6397
2020-547 FOI Services, Inc. 2019-10990
2020-588 brian asmus nicotinamide mononucleotide (NMN) drug patent
2020-559 Dhan AI 2017-8507, 2017-8508, 2017-8509, 2017-8510, 2017-8512.
2020-566 Gannett Government Media, Inc 2019-5706
2020-570 Qiyi Xie K904739; K013478
any and all documents within CFSAN, CDRH and CDER regarding oral safety of polyglycolic acid (PGA)
2020-552 GRAS Associates and polyglycolide, including documents containing data or analyses of data.
2020-550 Dhan AI 2019-11129 2019-11059 2019-11201 2019-10786 2019-6349
The EIR (in electronic format) for Human Drugs inspection of Ian M Baird MD ending 07/10/2019 at
2020-567 FDAZILLA the location in Columbus OH etc
2020-562 CONSUMER REPORTS 2019-10337, 2019-10472, 2019-11288, 2019-11598, 2019-11714, and 2019-4476.
the records detailing quantification levels or quantification ranges of salmonella strains that are
2020-587 Krista Powell known to be injurious to human and animal health
EXECUTIVE SUMMARY1 PRELIMINARY RECOMMENDATIONS ON TESTING METHODS FOR ASBESTOS IN
2020-579 Simmons Hanly Conroy TALC AND CONSUMER PRODUCTS CONTAINING TALC
2020-558 Courtney Juarez current organizational chart for the FDA.
2020-551 Dhan AI 2019-10642 2019-11044 2019-11060 2019-10838 2018-7805
2020-548 Dhan AI 2018-3216 2019-130 2019-129 2019-1393 2019-1514
2020-543 Dhan AI 2018-5681 2018-6632 2018-4486 2018-6826 2018-5266
2020-557 Courtney Juarez archived organizational charts for the last five years.
Company response from Lee Pharma Ltd. to the FDA-483 they received after inspection of Lee Pharma
2020-575 Carol Clark-Evans Ltd., 10 / G - 1 Survey No, Gaddipotharam, Telangana 502319, INDIA from 10/29/2018 - 11/2/2018
Studies, tests, reports, correspondence, emails, and all other documents relating to the weed killer
2020-580 Cunningham Bounds, LLC RoundUp manufactured by Monsanto.
listing of the entitles/websites seized in the attached article.
https://www.fda.gov/news-events/press-announcements/fda-dea-seize-44-websites-advertising-sale-
2020-595 Kimberly Buchanan illicit-thc-vaping-cartridges-us-consumers-part-operation
2020-545 BARCLAYS 2019-11770
2020-581 Scott Savedow PERONSAL RECS
Complete outbreak Line List for all confirmed cases of illness regarding Karoun Dairies, Inc., 2015
2020-586 Faegre Baker Daniels LLP Listeria Outbreak
2020-546 FOI Services, Inc. 2019-8880 2019-9166
The Response (in electronic format) for Human Drugs inspection of San Jorge Children's Hospital IRB
2020-568 FDAZILLA ending 09/09/2015 at the location in San Juan PR etc
Any and all documentation used by the FDA to approve the use of vetiver in alcoholic beverages in
2020-564 Wilderton 21CFR172.510.
2020-544 FOI Services, Inc. 2019-10474 and 2019-9743
spreadsheet which includes the 23 publicly available data points for all entries that led to the inclusion
of the following companies in this list: HomeGoods, Inc. AZ p10 HomeGoods, Inc. CA p76 Marshalls of
2020-577 Registrar Corp MA, Inc. AZ p11 T.J. Maxx of CA, LLC MA p339 The TJX Companies Inc CT p175 etc
Citizen’s petition from the Chocolate Manufacturers Association filed March 2, 1993 93P-0091/CP1
2020-593 Sheehan & Associates, P.C. copies of any comments
2020-582 Professional Disposables International, Inc. 3M™ SoluPrep™ Film-Forming Sterile Surgical Solution NDA 208288 filling and NDA supplements
I need Form 483 with 2 observation issued by USFDA to Lupin for inspection at its Nagpur facility for
2020-536 Nomura Financial Advisory & Securities (India) Private Limited the inspection held during 6 Jan 2020 to 10 Jan 2020. Please help me with the same. Thanks.
2020-502 Dhan AI 2015-4376 2015-6381 2015-7473 2014-4359 2014-5805
2020-492 Harrington Films 2019-10492
FDA-483 document for inspection of Lee Pharma Ltd., 10 / G - 1 Survey No, Gaddipotharam,
2020-507 Carol Clark-Evans Telangana 502319, INDIA from 10/29/2018 - 11/2/2018
Site Inspection Report and associated files, communications, and records related to the 2017 Site
Inspection of the Repro-Med Systems, Inc. (dba RMS Medical Systems, now KORU Medical Systems)
2020-539 EMED Technologies Corporation facility in Chester, New York.
2020-512 INTERNATIONAL SPECIALTY SUPPLY Tests performed on seed from Sprouts Unlimited or illnesses from eating at Jimmy Johns
2020-501 Dhan AI 2014-9204 2014-8508 2014-7656 2014-6869
2020-541 Osmotica Pharmaceutical US LLC Basis of approval from all review divisions (summary of approval) for NDA # 019407, Visine L.R.
483 issued to Chugai Pharma Manufacturing ; Utsunomiya, Japan; On CDER GMP inspection (190926
2020-524 Michiko Miyashita mm-2)
Request for Approved Documents of PROPRANOLOL HYDROCHLORIDE TABLETS, USP 10 mg, 20 mg, 40
2020-532 Mankind Pharma Ltd. mg, 60 mg and 80 mg- NDA No. 016418
2020-500 FDAZILLA 2016-8715, 2017-10375, 2017-10498, 2017-10499, 2017-10816
2020-497 FDAZILLA 2017-3496, 2017-3878, 2017-3901, 2017-4137, 2017-4796
MEDTRONIC - TOTAL HIP ARTHROPLASTY SYS K183129; JOHNSON & JOHNSON - UNFOLDER VITAN
INSERTER K191959; FRESENIUS MEDICAL CARE - DIASAFEPLUSUS K182367, ETC MTG MINS, LBLG,
2020-520 Elijah Wreh WARNING LTRS, ETC 10/3/16 TO 10/2/19
2020-526 Michiko Miyashita 483 issued to Kyowa Hakko Kirin; Takasaki, Japan : On CDER GMP inspection (191004 mm-3)
2020-499 FDAZILLA 2019-7666, 2019-7893, 2019-7970, 2019-8189, 2019-9055
2020-535 Dr Ajay Phadke Form 483 for Lupin's Tarapur Facility
2020-540 REED SMITH LLP REED SMITH LLP V FDA - CERTIFIED RECS
2020-523 Michiko Miyashita 483 issued to Astellas Pharma Tech: Toyama, Japan : at CDER GMP Inspection (191008 mm-1)
2020-512 INTERNATIONAL SPECIALTY SUPPLY Tests performed on seed from Sprouts Unlimited or illnesses from eating at Jimmy Johns
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
2020-506 GRAS Associates data or analyses of data.
2020-498 FDAZILLA 2019-2537, 2019-2540, 2019-4599, 2019-7092, 2019-7356
EIR, Untitled Letter for Novartis Pharmaeuticals 12/10/2018 - 12/14/2018 inspection in East Hanover,
2020-533 FOI Services, Inc. NJ
Review for initial submission of 1) ANDA 073585 (Sudafed 12 hour), date 10/31/1991. 2) NDA 020021
(Sudafed 24 hour), date 12/15/1992 Particular interest in the "Medical Review" section, and
2020-525 FAES Farma S.A. summaries of clinical studies.
2020-534 CHUBB QLIK SENSE - AERS
of poly(lactic-co-glycolic acid) (PLGA) and poly-lactide-co-glycolide, including documents containing
2020-506 GRAS Associates data or analyses of data.
2020-503 Advocate Lutheran General Hospital FAERS CASE REPORTS
2020-488 Dhan AI 2019-4990 2019-7986 2019-7955 2019-8236 2019-8473
EIR for the inspection that was conducted of Physio-Control, Inc. from November 5, 2019 through
2020-519 PHYSIO-CONTROL, INC. November 26, 2019.
2020-505 GRAS Associates of polylactic acid (PLA) and polylactide, including documents containing data or analyses of data.
2020-542 Sabiz Shabazz #41119086 Nutrient Content of the US Food Supply, 1909-2000
The Response (in electronic format) for Human Drugs inspection of Quality Chemical Laboratories, LLC
2020-460 FDAZILLA ending 07/27/2017 at the location in Wilmington NC etc
The EIR (in electronic format) for Biologics inspection of Abington Memorial Hospital,IRC ending
2020-468 FDAZILLA 02/15/2019 at the location in Abington PA, United States ETC
2020-438 Mexican Village Wholesale Foods dba Full Service Foods EIR report for Mexican Village Wholesale Foods dba Full Service Foods conducted on April 18, 2017
Summary basis of approval for Carbamazepine Tablets 200 mg for the following applicants: 1. Apotex
2020-473 Zydus Pharmaceuticals (USA) Inc. Inc. - A075948 2.Taro- A074649 3.Torrent (100,200,300,400mg) - A077272 4.Teva-A070541
The 483 (in electronic format) for Biologics inspection of SAFC Carlsbad, Inc. ending 09/12/2019 at
2020-453 FDAZILLA the location in Carlsbad CA, United States.
Any internal Chemistry or Toxicology Memoranda between FDA personnel in reference to Food
Contact Notifications (FCN) 1955, 1956 and 2007, all of which were submitted by me (Robert G.
2020-459 ARENT FOX LLP Edwards) of Arent Fox LLP on behalf of my client Coatex.
The EIR (in electronic format) for Biologics inspection of Biogen, Inc. ending 02/15/2019 at the location
2020-462 FDAZILLA in Research Triangle Park NC etc
correspondence to and from FDA, notes from any telephone conversations, text messages, emails and
email attachments, mentioning "Divi's Laboratories", "Divis Laboratories" or "3004149463" from
2020-452 NPR 11/01/2016 to present day.
the most recent copy available of the FDA Staff Manual Guide for the Division of Freedom of
2020-450 CONSUMER REPORTS Information
MEDISCA IN, PROFESSIONAL COMPOUNDING CENTERS OF AMERICA - COMMUNICATIONS PUBLISHING

2020-477 STYLIADES MEZZANOTTE & HASSON LAW OFCS ITS AVERAGE WHOLESALE PRICE FOR THE CONSTITUENT INGREDIENTS OF TOPICAL PAIN CREAMS
PRELIMINARY RECOMMENDATIONS ON TESTING METHODS FOR ASBESTOS IN TALC AND CONSUMER
2020-474 Simmons Hanly Conroy PRODUCTS CONTAINING TALC 1/6/20
2020-484 RICHARDSON ROSMARY DOES THE FDA AUTHORIZE TREATMENTS OR VACCINES FOR MINORS WITHOUT PARENTS CONSENT
Attn FOI Staff: copies of current procedures, policies and processes for issuing, redacting and web
2020-445 FOI Services, Inc. posting of untitled letters.
The 483 (in electronic format) for Medical Devices & Rad Health inspection of Richard E. Ringel, M.D.
2020-441 FDAZILLA ending 02/03/2009 at the location in Baltimore MD etc
2020-437 Orchid Orthopedic Solutions Medical Device Establishment Inspection Reports
The 483 (in electronic format) for Biologics inspection of Biogen, Inc. ending 03/23/2017 at the
location in Research Triangle Park NC, United States. The 483 (in electronic format) for Human Drugs
2020-454 FDAZILLA inspection of Rho, Inc. ending 06/30/2017 at the location in Chapel Hill NC, United States. etc
1. A copy of any letter from the FDA to Merck regarding any inspection at any time between March
2008 and the present by the FDA of Merck’s facility in West Point, Pennsylvania, concerning the
2020-451 Informed Consent Action Network Gardasil vaccine; etc
2020-467 PILLSBURY WINTHROP SHAW PITTMAN LLP RESPIRE PINK SERIES, RESPIRE PINK+, RESPIRE MEDICAL, ETC - COMMUICATIONS 1/1/19 TO PRESENT
CREATINE NITRATE NEW DIETARY INGREDIENT NOTIFICATION NUMBERS 696 AND 993 - STUDIES,
2020-482 VENABLE LLP RPTS, SUBMISSIONS
2020-478 SANDS ANDERSON PC INDIVIDUAL RECS - VAERS
Drug: Beovu Source of case #'s: FAERS FOIA Detailed Report - Beovu (11918) Requesting detailed
adverse event reports on the following cases: 17066853 17066866 17016414 17021640 17028081
17038140 17056025 17067923 17018440 17083773 17084801 17089194 17093392 17093714
17093735 17112839 17121843 17123570 17125644 17135628 17136363 17137469 17140758
2020-439 Pura Vida Investments 17144124 17142848
2020-483 LYSANDRA TAYLOR DARCY'S BOTANICALS LLC - RECS, ADDRESSES, PRODUCTS
records pretaining to meetings, correspondence, email, personnel involved directly with decision
making, committee members, etc. for Compass Pathways breakthrough designation status for
2020-448 Tyler McPhee research with psilocybin.
The 483 (in electronic format) for Human Drugs inspection of Ajinomoto Althea, Inc. ending
08/07/2019 at the location in San Diego CA, United States. The EIR (in electronic format) for Human
Drugs inspection of Ajinomoto Althea, Inc. ending 08/07/2019 at the location in San Diego CA, United
2020-455 FDAZILLA States.
The FDA records that describe the Agency’s assessment of the orphan designation for the condition of
2020-435 Regeneron Pharmaceuticals, Inc. hidradenitis suppurativa for Abbvie’s Humira (adalimumab).
1. Animal study proposals (ASPs), Institutional Animal Care and Use Committee (IACUC)-approved
protocols, amendments to protocols, laboratory notes, records of noncompliance, veterinary records,
photos, videos, inspection records, and/or complaints regarding any and all animals used in
2020-430 PEOPLE FOR THE ETHICAL TREATMENT OF ANIMALS experiments and/or procedures etc
FAP 8A4821 (Docket ID: FDA-2018-F-3230), the food additive petition submitted by Oakshire Naturals
LP to amend food additive regulations to provide for the safe use of vitamin D2 mushroom powder as
2020-429 EXPONENT, INC. a nutrient supplement in specific food categories.
2020-428 BASF - The Chemical Company FCN #001152 and corresponding chemistry and toxicology memos
2020-421 OFW LAW summary of animal food inspections
2020-416 FDAZILLA Shelby Brown CV
The 483 (in electronic format) for Foods & Cosmetics inspection of Wayne Distribution Center, LLC
2020-433 FDAZILLA dba: Premier Meat Company ending 09/25/2019 at the location in Vernon CA, United States
483 issued to Hisamitsu Pharmaceutical Co., Inc.; Utsunomiya, Japan; On CDER Drug Quality Assurance
2020-425 Xpro associates, LLC Inspection (191011 km1)
The EIR (in electronic format) for Human Drugs inspection of Anil Kumar, M.D. ending 11/02/2011 at
2020-420 FDAZILLA the location in Lancaster CA, United States.
Princeton Consumer Research Corp. (PCR), Baypoint Commerce Center 9600 Koger Blvd N, St
Petersburg, FL, 33702 is registered as a clinical testing company with the FDA's Volunteer Cosmetic
2020-427 Andy Wise Registration Program.
Any released 483s and EIRs for inspections (GMP, GCP or otherwise) of makers of drugs, devices and
2020-424 Washington Info. Source/Inspection Monitor newsletter biologicals.
2020-431 OFW LAW FSVP inspection summary
Citizen Petitions (including petitions for stay of agency action) submitted to the FDA over the course of
2020-374 PROPUBLICA the last three years
2020-415 SANDS ANDERSON PC INDIVIDUAL RECS
2020-408 COSMETIC INGEDIENT REVIEW VCRP DATA - CATEGORY FREQUENCY OF USE TOTALS, INGREDIENT, AND CATEGORY
483 issued to Sumika Chemical Analysis Service, Ltd. ; Oita, Japan; on CDER Drug Quality
2020-398 Xpro associates, LLC Assurance Inspection (191113 km-2)
483 issued to Sumitomo Dainippon Pharma Co., Ltd. ; Suzuka, Japan ; on CDER Drug Quality Assurance
2020-397 Xpro associates, LLC Inspection (191122 km-3)
Product area: Drugs Types of records: approval records Documents referencing the compound "lysine
2020-383 Shehadeh Giannamore PLLC clonixinate"
Complete Summary Basis of Approval of the Original NDA, CLARITIN-D (LORATADINE;
2020-378 Dr. Reddys Laboratories PSEUDOEPHEDRINE SULFATE), NDA #019670 approved on 11/14/1994.
spreadsheet listing the 23 publicly available data points for all Notices of FDA Action issued during the
2020-372 Registrar Corp time frame between October 1, 2019 and December 31, 2019
2020-396 Cogencis Information Services Form 483 issued by the FDA to Sun Pharmaceutical Industries Ltd's facility at Bharuch, Gujarat, India.
The 483 (in electronic format) for Human Drugs inspection of Azazuddin A. Ahmed, MD ending
2020-390 FDAZILLA 11/08/2013 at the location in Chicago IL, United States. ETC
2020-399 BASF - The Chemical Company FCN #1927 and corresponding chemistry and toxicology memos
The 483 (in electronic format) for Biologics inspection of SAFC Carlsbad, Inc. ending 09/12/2019 at
2020-393 FDAZILLA the location in Carlsbad CA, United States.
spreadsheet identifying the name and contact information related to each Drug Master File (DMF)
2020-371 Registrar Corp Original Submission from January 1, 1975, to December 31, 1975
For entry number 788-1712230-8 we would like to receive pictures showing the findings described in
the “Notice of FDA Action”. Also, all the available lab results, testings, images, examination results and
data. All images, lab results and identification data showing the findings of putrid or decomposed
substances found in the samples tested: cat hairs, unknown striated hairs, plastic fragment,and insect
2020-400 VDG Brands LLC fragments.
2020-385 CSL BEHRING Summary Basis of Approval for NDA 202057/S-035 – VASCEPA
The EIR (in electronic format) for Human Drugs inspection of Steven Rohrbeck ending 05/06/2013 at
the location in High Point NC, United States. The Response (in electronic format) for Human Drugs
2020-382 FDAZILLA inspection of Steven Rohrbeck ending 05/06/2013 at the location in High Point NC, United States. ETC
2020-370 FOI Services, Inc. MedWatch Case # 3234634, regarding risperidone.
dba: Premier Meat Company ending 09/25/2019 at the location in Vernon CA, United States. The EIR
(in electronic format) for Human Drugs inspection of Anil Kumar, M.D. ending 11/02/2011 at the
2020-367 FDAZILLA location in Lancaster CA, United States.
2020-365 FDAZILLA dba: Premier Meat Company ending 09/25/2019 at the location in Vernon CA, United States.
2020-409 MULLER BRAZIL LLP INDIVIDUAL RECS
2020-405 Rohit Vanjani HERON THERAPEUTICS - HTX-011 NDA, CO RESP
2020-403 JOSEPH FANELLI FDA-ORA-19-MP-10586967DY SELECTION
Requesting MedWatch reports for the following FAER primary case IDs: SUSTOL suspect: 16655938
aprepitant suspect: 15450385 15405872 15405867 15405799 15403380 13915943 Exparel suspect:
2020-401 HERON THERAPEUTICS INC 10926372 12592329 14825369 14841852 16656303
2020-389 Bug Juice COMPLAINT RECS 158936
FSVP spreadsheet which includes the 23 publicly available data points for all entries that led to our
2020-373 Registrar Corp company's inclusion in this list as of 12/31/2019 or the most recently available date.
2020-406 STERLING POLLARD INDIVIDUAL RECS
The EIR (in electronic format) for Medical Devices & Rad Health inspection of Karl Storz Endoscopy
2020-394 FDAZILLA ending 04/16/2018 at the location in El Segundo CA, United States.
2020-414 WILSON SONSINI ET AL 2018-8083 RESP
2020-407 Paul LLP AMAG PHARMACEUTICALS INC - MAKENA NDA 021945 APRVL
spreadsheet identifying the firms that received FDA Warning Letters between October 1, 2011, and
2020-379 Registrar Corp December 31, 2019
2020-410 MULLER BRAZIL LLP INDIVIDUAL RECS
2020-386 Paul LLP Any and all regulatory correspondence concerning Chlopyrifos and Dow Agrosciences LLC
FAERS data for Oxbryta (voxelotor) and Adakveo (crizanlizumab) from January, 2019 to present,
2020-368 DEERFIELD INSTITUTE including detailed FOIA reports in excel/CSV format.
2020-366 FDAZILLA location in Lancaster CA, United States.
2020-412 SEYFARTH SHAW LLP TALCUM POWDER - DOCS 4/13/18 TO PRESENT
2020-380 FDAZILLA location in Lancaster CA, United States. ETC
2020-413 LEVI & KORSINSKY LLP SIOUX HONEY ASSOCIATION CORR BETWEEN FDA
2020-413 LEVI & KORSINSKY LLP SIOUX HONEY ASSOCIATION CORR BETWEEN FDA
2020-363 ANALYSIS GROUP INC ZYKADIA (CERITINIB) NDA 205755 APRVL
Any and all approvals between 2014-Current for neurological implants. In particular, please provide
any and all approval documentation for graphene based implants and any documentation regarding
2020-320 Anthony Lauzon technology whether proposed or otherwise involving the University of Pennsylvania.
2020-336 ANALYSIS GROUP INC SUTENT (SUNITINIB MALATE) NDA 021938 APRVL
2020-342 ANALYSIS GROUP INC TIBSOVO (IVOSIDENIB) NDA 211192
2020-357 ANALYSIS GROUP INC TRUXIMA (RITUXIMAB-ABBS) NDA 761088 APRVL
2020-353 ANALYSIS GROUP INC LONSURF (TRIFLURIDINE & TIPIRACIL) NDA 207981 APRVL
2020-346 ANALYSIS GROUP INC REVLIMID (LENALIDOMIDE) NDA 021880 APRVL
2020-347 ANALYSIS GROUP INC POMALYST (POMALIDOMIDE) NDA 204026 APRVL
2020-344 ANALYSIS GROUP INC RUBRACA (RUCAPARIB) NDA 209115 APRVL
2020-324 Susan Manley LLC Rare Pediatric Priority Review Voucher Request for Vyondys 53 (golodirsen)
1. Novartis' Zolgensma 2. Bristol's Reblozyl 3. Insmed's Arikayce 4. Portola's Andexxa 5. Ultragenyx's
2020-323 CREDIT SUISSE Crysvita AERS
2020-326 Genentech Ultomiris (ravulizumab-cwvz) supplemental BLA summary basis of approval review
2020-348 ANALYSIS GROUP INC PERJETA (PERTUZUMAB) NDA 125409 APRVL
2020-360 ANALYSIS GROUP INC XALKORI (CRIZOTINIB) NDA 202570 APRVL
2020-341 ANALYSIS GROUP INC TECENTRIQ (ATEZOLIZUMAB) NDA 761034 APRVL
2020-356 ANALYSIS GROUP INC TRISENOX (ARSENIC TRIOXIDE) NDA 021248 APRVL
2020-340 ANALYSIS GROUP INC TASIGNA (NILOTINIB) NDA 022068
2020-349 ANALYSIS GROUP INC OPDIVO (NIVOLUMAB)
Human adverse event drug MedWatch reports for the following Case IDS: 12215851 12645427
12701921 12706202 12744594 12820587 12845555 12971147 13004060 13013665 13657626
2020-325 The Weinberg Group 14914667
2020-361 ANALYSIS GROUP INC XTANDI (ENZALUTAMIDE) NDA 203415 APRVL
2020-359 ANALYSIS GROUP INC VENCLEXTA (VENETOCLAX) NDA 208573 APRVL
Establishment Inspection Reports, 483s, Observations, Warning Letters, Responses, all company
correspondences. Aptuit (Oxford) Ltd, a UK-based subsidiary of Evotec, located at 110-111 Innovation
2020-330 Bridger Healthcare Drive, Abingdon, Oxfordshire OX14 4RZ, United Kingdom (GBR)
2020-337 ANALYSIS GROUP INC TAFINLAR (DABRAFENIB) NDA 202806 APRVL
2020-333 BJA, LLC summary basis of approval (SBA) for the NDA 202860 (Genosyl by Vero Biotech).
23 publicly available data points for all system May Proceeds and ER May Proceeds issued during the
2020-332 Registrar Corp time frame between October 1, 2019 through December 31, 2019
Changes in size, budget and mission in the last 5 years (especially any changes since the beginning of
2020-327 Courtney Juarez the Trump Administration) • ETC
2020-354 ANALYSIS GROUP INC KYPROLIS (CARFILZOMIB) NDA 202714 APRVL
2020-334 ANALYSIS GROUP INC SOMATULINE DEPOT (LANREOTIDE) NDA 022074 APRVL
2020-350 ANALYSIS GROUP INC MVASI ( BEVACIZUMAB-AWWB) NDA 761028 APRVL
Form 483s issued after the Inspection conducted between November 4-8, 2019 at Calyx Chemicals &
Pharmaceuticals Limited, N-102/91, MIDC, Tarapur, Boisar, Dist. Palghar, Maharashtra 401506, India;
2020-322 TerSera Therapeutics LLC FEI: 3003721861
2020-335 ANALYSIS GROUP INC SPRYCEL (DASATINIB) NDA 021986 APRVL
2020-358 ANALYSIS GROUP INC VECTIBIX (PANITUMUMAB) NDA 125147 APRVL
2020-355 ANALYSIS GROUP INC LENVIMA (LENVATINIB) NDA 206947 APRVL
2020-352 ANALYSIS GROUP INC LYNPARZA (OLAPARIB) NDA 208558 APRVL
2020-343 ANALYSIS GROUP INC TOPOTECAN HYDROCHLORIDE INJECTION NDA 022453 APRVL
2020-362 ANALYSIS GROUP INC YERVOY (IPILIMUMAB) NDA 125377 APRVL
2020-345 ANALYSIS GROUP INC RITUXAN (RITUXIMAB) NDA 103705 APRVL
2020-351 ANALYSIS GROUP INC MEKINIST (TRAMETINIB) NDA 204114 APRVL
2020-339 ANALYSIS GROUP INC TARCEVA (ERLOTINIB) NDA 021743 APRVL
2020-338 ANALYSIS GROUP INC TAGRISSO (OSIMERTINIB) NDA 208065 APRVL
2020-364 ANALYSIS GROUP INC ZYTIGA (ABIRATERONE ACETATE) NDA 202379 APRVL
2020-285 ANALYSIS GROUP INC GILOTRIF (AFATINUB) NDA 201-192/S7,S14 - APRVL LTR, LBLG, RVWS, ETC
2020-313 Dhan AI 2019-3902 2019-480 2018-5622 2018-4724 2018-3859
2020-307 Dhan AI 2018-2391 2018-2392 2018-2393 2018-2394 2018-2395
2020-298 ANALYSIS GROUP INC ARZERRA (OFATUMUMAB) BLA 125326 - APRVL LTR, LBLG, RVWS, ETC
2020-274 FOI Services, Inc. EIR December 18-20, 2018 for Smokin Joe's, Lewiston, NY.
FEI # 3008461619 "Notice of Inspection Observations" Aurobindo Pharma Ltd- Unit IV Plot Nos. 4, 34
to 48, EPIP, TSIIC, IDA, Pashamylaram, Patancheru Mandal, Sangareddy Medak District, Hyderabad,
2020-253 ECI Pharmaceuticals, LLC Telangana, 502307, India
Records pertaining to FDA investigation of SURE-PD3 drug trial testing inosine for Parkinson's Disease,
2020-251 Diane Slavik specifically at Northwestern University in Chicago, Tanya Simuni, principal investigator.
Establishment Inspection Report, Form FDA 483 and Correspondence: Josefa Binker, M.D.
2020-236 Thomson Reuters - Clarivate Analytics Homestead, FL End Dates of inspection: Thursday, July 25, 2019
2020-273 ANALYSIS GROUP INC ALIMTA (PEMETREXED) NDA 21-462/S51,S53 - APRVL LTR, LBLG, RVWS, ETC
2020-283 ANALYSIS GROUP INC HERZUMA (TRASTUZUMAB-PKRB) BLA 761091/S2 - APRVL LTR, LBLG, RVWS, ETC
2020-300 Dhan AI 2016-7743 2016-7808
2020-299 Dhan AI 2017-2697 2017-380 2017-4124 2017-5273 2017-6072
2020-268 FMC USA Corporation FMC Corporation, Lithium Division Bessemer City, NC INSPECTION REPORT
Establishment Inspection Reports Lilly Nus Center for Clinical Pharmacology; FEI # 3004358483; 10
2020-259 Eli Lilly and Company Medical Drive, Singapore, Singapore; ETC
2020-312 Dhan AI 2018-691 2018-3853 2019-9653 2019-5017 2019-1565 2019-3063
2020-291 ANALYSIS GROUP INC DARZALEX (DARATUMUMAB) BLA 761036/S3,S4,S5, ETC - APRVL LTR, LBLG, RVWS, ETC
2020-234 Thomson Reuters - Clarivate Analytics Form FDA 483 : Mission Hills, S.A. de C.V. ,San Jose Iturbide, Mexico
2020-231 CHILDREN'S HOSPITAL OF PHILADELPHIA Children's Hospital of Philadelphia EIR andcorrespondence between the FDA and Dr. Rome
2020-277 ANALYSIS GROUP INC ADCETRIS (BRENTUXIMAB VEDOTIN) BLA 125388/S80,S94,S97,S99 - APRVL LTR, LBLG, RVWS, ETC
2020-286 ANALYSIS GROUP INC GAZYVA (OBINUTUZUMAB) BLA 125486/S13,S17 - APRVL LTR, LBLG, RVWS, ETC
2020-284 ANALYSIS GROUP INC HALAVEN (ERIBULUIN MESYLATE) NDA 201-532 - APRVL LTR, LBLG, RVWS, ETC
2020-302 Dhan AI 2017-6610 2017-6972 2017-7421 2016-3188 2016-4075
Copies of the FOIA documents for 483 and EIR records of the inspection conducted during 10/04/2018
2020-241 AGC Biologics - 10/15/2018 at AGC Biologics, FEI 3000209996
2020-306 Dhan AI 2018-2385 2018-2386 2018-2387 2018-2388 2018-2389
2020-304 Dhan AI 2018-2363 2018-2364 2018-2373 2018-2374 2018-2375
Establishment Inspection Reports Lilly Nus Center for Clinical Pharmacology; FEI # 3004358483; 10
2020-259 Eli Lilly and Company Medical Drive, Singapore, Singapore; ETC
2020-261 NPR 2019-10657
Establishment Inspection Report for Biozone Laboratories, Inc. located at 580 Garcia Avenue,
2020-255 Laser Pharmaceuticals, LLC Pittsburg, CA 94565 conducted on 05/13/2019
2020-254 Relypsa, Inc. FAERS detailed database report on Veltassa or Patriomer from 01-Jul-2019 to 12-Dec-2019.
2020-288 ANALYSIS GROUP INC ERLEADA (APALUTAMIDE) NDA 210-951/S1 - APRVL LTR, LBLG, RVWS, ETC
2020-305 Dhan AI 2018-2376 2018-2381 2018-2382 2018-2383 2018-2384
2020-295 ANALYSIS GROUP INC BLINCYTO (BLINATUMOMAB) BLA 125557/S8,S13 - APRVL LTR, LBLG, RVWS, ETC
2020-290 ANALYSIS GROUP INC DOCEFREZ (DOCETAXEL) NDA 22-534/S7 - APRVL LTR, LBLG, RVWS, ETC
2020-270 ADVANCED STERILIZATION PRODUCTS Establishment Inspection Report (EIR) 2015 Inspection for Advanced Sterilization Products
2020-296 ANALYSIS GROUP INC BAVENCIO (AVELUMAB) BLA 761049/S6 - APRVL LTR, LBLG, RVWS, ETC
2020-279 ANALYSIS GROUP INC KEVTRUDA (PEMBROLIZUMAB) BLA 125514/S4,S5,S6, ETC - APRVL LTR, LBLG, RVWS, ETC
2020-260 NPR 2019-11178
certified copy of the Establishment Inspection Report for an inspection performed at Changzhou STA
2020-256 STA Pharmaceutical Co., Ltd. A subsidiary of WuXi AppTec Pharmaceutical in China
Communication between Jin Yang-Gon, the chief executive officer of HLB, and FDA staff with regard to
the drug rivoceranib (apatinib). I am looking for IND, NDA, pre-NDA meeting notes and any other
2020-248 BLOOMBERG NEWS formal correspondence by letter or email.
KISQALI FEMERA CO-PACK (RIBOCICLIB AND LETROZOLE) NDA 209-935/S2 - APRVL LTR, LBLG, RVWS,
2020-278 ANALYSIS GROUP INC ETC
2020-310 Dhan AI 2019-7956 2019-7587 2019-7951 2019-1932
2020-293 ANALYSIS GROUP INC CABOMETYX (CABOZANTINIB) NDA 208-692/S2/S3 - APRVL LTR, LBLG, RVWS, ETC
A digital list of every prescription drug that has appeared on the FDA shortage list in the past 7 years.
2020-250 Michaela Morgan Specifically injectables if possible.
2020-240 IPD ANALYTICS LLC ANDA No. 208778 for Moxifloxacin
Establishment Inspection Report, Form FDA 483 and Correspondence: Hoveround Corporation
2020-232 Thomson Reuters - Clarivate Analytics Sarasota, FL End Dates of inspection: Friday, June 14, 2019 FDA District Office: Florida District
2020-275 ANALYSIS GROUP INC ALECENSA (ALECTINIB) NDA 208-434/S03 - APRVL LTR, LBLG, RVWS, ETC
The Original Approval Letter for NDA 017808 (Miacalcin) The Summary Basis of Information for NDA
2020-252 Xiromed LLC 017808.
2020-287 ANALYSIS GROUP INC FASLODEX (FULVESTRANT) NDA 21-344/S34,S35,S37 - APRVL LTR, LBLG, RVWS, ETC
2020-281 ANALYSIS GROUP INC IMFINZI (DURVALUMAB) BLA 761069/S2 - APRVL LTR, LBLG, RVWS, ETC
2020-301 Dhan AI 2016-4885 2016-527 2016-5466 2016-630 2016-6315 2016-7310
Establishment Inspection Report, Form FDA 483 and Correspondence: Jacob W. Zeiders III, M.D.
2020-238 Thomson Reuters - Clarivate Analytics Fort Lauderdale, FL End Dates of inspection: Tuesday, September 24, 2019 FDA
2020-271 NutraSource, Inc. original submission and the correspondences of GRN 845 for Lactobacillus rhamnosus LGG.
2020-269 Swiss-American CDMO 483 from June 2019 for Cross Brands Contract Filling, LLC. located in Florida.
2020-263 Zydus Pharmaceuticals USA Inc. approved labels of NDA 011751, PROLIXIN Tablets
2020-282 ANALYSIS GROUP INC IMBRUVICA (IBRUTINIB) NDA 205-552/S2,S7,S10, ETC - APRVL LTR, LBLG, RVWS, ETC
2020-292 ANALYSIS GROUP INC CYRAMZA (RAMUCIRUMAB) BLA 125477/S11/S29 - APRVL LTR, LBLG, RVWS, ETC
2020-234 Thomson Reuters - Clarivate Analytics Form FDA 483 : Mission Hills, S.A. de C.V. ,San Jose Iturbide, Mexico
2020-311 Dhan AI 2014-9204 2013-5745
List of expiry dates of patents on drugs with expiry date within the period 1996-2008. Each record
2020-249 IMT Lucca should contain the following 3 entries: (i) drug name (ii) expiry date (iii) ATC class.
supplements sold by "Trim Pill Keto" on Amazon.com (see hyperlink
2020-237 Jackson Pavelka &marketplaceID=ATVPDKIKX0DER
2020-235 Thomson Reuters - Clarivate Analytics Form FDA 483: Miele & Cie. KG, Oelde, Germany End dates of inspection: April 19, 2018
2020-262 NPR 2019-10648
2020-257 AndersonBrecon Inc. ANDERSONBRECON INC INSPECTION RECS
2020-280 ANALYSIS GROUP INC KADCVLA (ADO-TRASTUZUMAB EMTANSINE) BLA 125427 - APRVL LTR, LBLG, RVWS, ETC
2020-308 Dhan AI 2019-140 2019-2720 2019-2905 2019-2962 2019-3067
2020-309 Dhan AI 2019-3111 2019-3157 2019-3305 2019-3587 2019-3592
2020-303 Dhan AI 2016-8468 2016-9094 2016-9998 2017-1508 2017-2475
2020-294 ANALYSIS GROUP INC BOSULIF (BOSUTINIB) NDA 203-341/S9 - APRVL LTR, LBLG, RVWS, ETC
2020-289 ANALYSIS GROUP INC EMPLICITI (ELOTUZUMAB) BLA 761035/S8 - APRVL LTR, LBLG, RVWS, ETC
2020-258 AndersonBrecon Inc. ANDERSONBRECON INC INSPECTION RECS
2020-297 ANALYSIS GROUP INC AVASTIN (BEVACIZUMAB) BLA 125085/S317.S319.S323 - APRVL LTR, LBLG, RVWS, ETC
2020-276 ANALYSIS GROUP INC AFINITOR (EVEROLIMUS) NDA 22-334/S32,S35,S36 - APRVL LTR, LBLG, RVWS, ETC
2020-224 LEARMONT PHARMACEUTICALS BENOQUIN NDA 08-173, NDA 10-253 - DESI RVWS
Establishment Inspection Report, Form FDA 483 and Correspondence: Tektone Sound & Signal
Mfg.Inc. Franklin,NC End Dates of inspection: Thursday, September 26, 2019 FDA District Office:
2020-187 Thomson Reuters - Clarivate Analytics Atlanta
Establishment Inspection Report, Form FDA 483 and Correspondence: Klyo Medical Systems, Inc.
2020-179 Thomson Reuters - Clarivate Analytics Doral, FL End Dates of inspection: Thursday, July 18, 2019 FDA District Office: Florida District
Establishment Inspection Report, Form FDA 483 and Correspondence: Cupron Inc. Richmond, VA
2020-177 Thomson Reuters - Clarivate Analytics End Dates of inspection: Thursday, September 19, 2019 FDA District Office: Baltimore
2020-220 MULLER BRAZIL LLP INDIVIDUAL RECS - NATIONAL VACCINE INJURY COMPENSATION PROGRAM (NVICP)
all FOIA requests filed with FDA’s Center for Food Safety and Applied Nutrition (“CFSAN”), including
2020-193 BEVERIDGE & DIAMOND related offices, from September 1, 2019 through September 30, 2019
Establishment Inspection Report, Form FDA 483 and Correspondence: Mark Two Engineering Inc.
2020-192 Thomson Reuters - Clarivate Analytics Miami Lakes, FL End Dates of inspection: Tuesday, August 06, 2019 FDA District Office: Florida
2020-221 MULLER BRAZIL LLP INDIVIDUAL RECS - NATIONAL VACCINE INJURY COMPENSATION PROGRAM (NVICP)
2020-206 Bursor & Fisher, P.A. TESTING RECS TAYLOR FARMS ETC
2020-202 Sonya Johnson INDIVIDUAL RECS
WHARTON SCHOOL OF THE UNIVERSITY OF PENNSYLVANIA,

2020-204 DEPARTMENT OF LEGAL STUDIES HHSF223201210042I, HHSF223201010028B, and HHSF223201210039I
2020-147 BENJAMIN L ENGLAND & ASSOCIATES LLC IMPORT EXAMINATIONS, IMPORT DETENTIONS, OASIS IMPORT LINES, ETC 10/1/19 TO 12/31/19
2020-146 COLOPLAST CORP HCPCS LEVEL II CODE A4353 INTERMITTENT URINARY CATHETER WITH INSERTION SUPPLIES
2020-229 AMERICAN CLEANING INSTITUTE PUBLIC ADMIN FILE VOL 230001 BOOK OF 3
2020-225 ENVISAGE CONSULTING LLC ANTIMICORBIAL A/C MTG 10/12/1979; 1980N-0476
2020-152 Dhan AI 2017-9814 2017-9816 2017-9827 2017-9829 2017-9831
2020-206 Bursor & Fisher, P.A. TESTING RECS TAYLOR FARMS ETC
2020-145 MUCKROCK NEWS PRUDUE PHARMA LP - OXYCONTIN NDA 20-553 ATTACHMENTS, EXHIBITS, APPLICATION
All 2019 Field Alert Reports for the following products a. CVS Preservative Free Lubricant Eye
Drops Lot No.: 8AV1057, exp 07/19. b. CVS Preservative Free Lubricant Eye Drops Lot No.: SBF
exp 02/21. 2. All 2019 Adverse Event Reports for the following products a. CVS Preservative
Free Lubricant Eye Drops Lot No.: 8AV1057, exp 07/19. b. CVS Preservative Free Lubricant Eye
Drops Lot No.: SBF exp 02/21. 3. All 2019 documents related to FAERS Case ID Nos.: a.
16590804 CVS Lubricant Eye Drops b. 16577545 CVS Long lasting Lubricant Eye c.
2020-203 Gentile & Associates 16815985 CVS Lubricant Eye drops
2020-154 Dhan AI 2018-1079 2018-1088 2018-1110 2018-1112 2018-1113
2020-153 Dhan AI 2018-1119 2018-1969 2018-2119 2018-2120 2018-2362
Establishment Inspection Report, Form FDA 483 and Correspondence: Energetix Corporation
2020-188 Thomson Reuters - Clarivate Analytics Dahlonega,GA End Dates of inspection: Thursday, June 13, 2019 FDA District Office: Atlanta
2020-185 University of Bath list of all of the FDA approved topical generic drugs to date
2020-213 Zydus Pharmaceuticals USA Inc. NDA 050742
EIR, 483, CORR Ecotec Manufacturing, Inc. Okeechobee, FL End Dates of inspection: Wednesday, June
2020-210 Thomson Reuters - Clarivate Analytics 26, 2019 FDA District Office: Florida
2020-158 Dhan AI 2018-2964 2018-2965 2018-3697 2018-435 2018-436
2020-230 ENVISAGE CONSULTING LLC DKT 1975N-0183, DKT 1981N-0033
Establishment Inspection Report, Form FDA 483 and Correspondence: O.L. Products Inc. Oldsmar, FL
2020-191 Thomson Reuters - Clarivate Analytics End Dates of inspection: Wednesday, August 14, 2019 FDA District Office: Florida
All submitted documents for Device: Primary Antibody; anti-ALK (D5F3) Rabbit Monoclonal for ALK-
2020-174 Globizz Corp. ALCL, Manufacturer: Ventana Medical Systems, Inc.
2020-159 Dhan AI 2018-6364 2018-6397 2018-6648 2018-7136 2018-7146
Establishment Inspection Report, Form FDA 483 and Correspondence: Pablo H. Vivas, M.D. Miami
2020-190 Thomson Reuters - Clarivate Analytics Beach, FL End Dates of inspection: Thursday, August 22, 2019 FDA District Office: Florida
Establishment Inspection Report, Form FDA 483 and Correspondence: Sound & Signal Mfg.Inc.
2020-176 Thomson Reuters - Clarivate Analytics Franklin, NC End Dates of inspection: Thursday, September 26, 2019 FDA District Office: Atlanta
Establishment Inspection Report, Form FDA 483 and Correspondence: Sarasota Medical Products Inc
2020-186 Thomson Reuters - Clarivate Analytics Sarasota, FL End Dates of inspection: Wednesday, June 12, 2019 FDA District Office: Florida District
Establishment Inspection Report, Form FDA 483 and Correspondence: Cancer Diagnostics Inc.
2020-178 Thomson Reuters - Clarivate Analytics Durham, NC End Dates of inspection: Wednesday, August 14, 2019 FDA District Office: Atlanta
FDA'S EFFORTS TO DETERMINE THE SOURCE OF CONTAMINATION OD E COLI IN ROMAINE LETTUSE
2020-217 SEVERSON & WERSON HARVESTED IN THE SALINAS GROWING REGION IN 2019
any and all Establishment Inspection Reports for The Real Meat Company plant located at 14122 Aetna
2020-211 Amelia Zimmaro St Van Nuys, CA 91401 since January 1, 2015.
2020-219 CONWAY HOMER PC INDIVIDUAL RECS - NATIONAL VACCINE INJURY COMPENSATION PROGRAM (NVICP)
2020-149 BOYLE BRASHER LLC MISSOURI SUGAR INC - INCIDENT WHERE RUBBER WAS FOUND IN THE SUGAR
2020-150 Dhan AI 2017-9356 2017-9808 2017-9809 2017-9810 2017-9813
2020-218 MAZIE SLATER KATZ & FREEMAN LLC BAYER CORP, CONCEPTUS INC - ESSURE DVC MDRS, LBLG CHANGES, COMM, ETC
RECS RE INITIAL ADOPTION OF DEFINITIONSA ND STANDARDS OF IDENTITY FOR MOZZARELLA CHEESE
2020-205 UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN ADN SCAMORZA CHEESE
2020-148 LIPSITZ & PONTERIO LLC XELJANZ - ISRS 12635123, 15426470, 15344239, ETC
2020-228 JOAN ZINZEN DKT 1980A-0209
Any and all reports involving the interaction of warfarin/Coumadin and Mobic (Meloxicam), including
2020-195 Snyder & Wenner, P.C. serious bleeding events and/or deaths.
2020-214 SHIMON ROSENBERG ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES 6/95
Complete response letter (CRL’s) to New drug applications (NDAs) and abbreviated new drug
applications (ANDAs) issued by the FDA to Bausch + Lomb plant at Tampa, FL, during the range of
years 2016 - to present. Any response letters from Bausch Health Companies to these FDA’s CRL
related to the release drugs and medical devices i.e., Vyzulta, Lumify, Rhopressa (Aerie
Pharmaceuticals, Inc. contract manufacture) manufacture at the above mentioned cite If there are
2020-175 Carlos Ramirez any other new drugs or medical devices produce at this specific plant please include them.
2020-160 Valiant Capital ALL detailed adverse events reports for Epidiolex.
2020-157 Dhan AI 2018-437 2018-4787 2018-4788 2018-5514 2018-5548
2020-156 Dhan AI 2018-2601
2020-155 Dhan AI 2017-9835 2017-9892 2017-9893 2017-9894 2018-1078
COMMUNICATIONS AND DOCUMENTATION REGARDING AN INCIDENT INVOLVING H-E-B WHERE
2020-151 BOYLE BRASHER LLC THERE WAS FOUND TO CONTAIN RUBBER IN THEIR CAKE ICING
2020-227 FSI RESEARCH & SERVICES, INC. DERMATOLOGIC & OPHTHALMIC DRUGS A/C MTG 9/5/97
2020-226 AMERICAN HERBAL PRODUCTS ASSOCIATION DKT 2017S-0073
Establishment Inspection Report, Form FDA 483 and Correspondence: Energetix Corporation
2020-188 Thomson Reuters - Clarivate Analytics Dahlonega,GA End Dates of inspection: Thursday, June 13, 2019 FDA District Office: Atlanta
COMMUNICATIONS AND DOCUMENTATION REGARDING TWO INCIDENTS OCCURRING ON OR ABOUT
9/16/19 AND 9/22/19 INVOLVING TWINSTARS BAKERY WHERE THEIR CAKE ICING WAS FOUND TO
2020-196 BOYLE BRASHER LLC CONTAIN RUBBER
Establishment Inspection Report, Form FDA 483 and Correspondence: RMG ART Laboratories, Inc.
2020-189 Thomson Reuters - Clarivate Analytics Temple Terrace, FL End Dates of inspection: Friday, July 12, 2019 FDA District Office: Florida
2020-208 Thomson Reuters - Clarivate Analytics Establishment Inspection Report, Form FDA 483 and Correspondence: AcuLux, Inc. Naples, NC
2020-207 Sunshine Lake Pharma Co., Ltd. NDA212895
TORRENT PHARMACEUTICALS INC - MINOCYCLINE HCL LBLG, MEDICATION GUIDES, INSTRUCTIONS
2020-215 ROGAK GIBBONS & DE SIVER LLP FOR USE, ETC 2017
Establishment Inspection Report, Form FDA 483 and Correspondence: Boca Dental Supply LLC Boca
2020-209 Thomson Reuters - Clarivate Analytics Raton, NC End Dates of inspection: Monday, July 22, 2019 FDA District Office: Florida
Establishment Inspection Report, Form FDA 483 and Correspondence: Mary Kay, Inc Dallas, TX End
2020-121 Thomson Reuters - Clarivate Analytics Dates of inspection: Friday, July 19, 2019 FDA District Office: Dallas
Establishment Inspection Report, Form FDA 483 and Correspondence: LUBRINOVATION, Inc.
2020-132 Thomson Reuters - Clarivate Analytics Frederick, MD End Dates of inspection: Wednesday, August 07, 2019 FDA District Office: Baltimore
Establishment Inspection Report, Form FDA 483 and Correspondence: Woodfield Pharmaceutical,
2020-122 Thomson Reuters - Clarivate Analytics LLC Houston, TX End Dates of inspection: Thursday, July 11, 2019 FDA District Office: Dallas
2020-94 Steptoe & Johnson LLP ALTAIRE PHARMACEUTCIALS RECALL RECS
Establishment Inspection Report, Form FDA 483 and Correspondence: Infinite Biomedical
Technologies Baltimore, MD End Dates of inspection: Tuesday, July 30, 2019 FDA District Office:
2020-134 Thomson Reuters - Clarivate Analytics Baltimore
2020-93 Wegman Hessler SMUCKER PET FOOD RECALL RECS
Hoxworth Blood Center University of Cincinnati Medical Center Cincinnati, OH End Dates of inspection:
2020-138 Thomson Reuters - Clarivate Analytics Wednesday, September 04, 2019 FDA District Office: Cincinnati
2020-95 Dhan AI Inc 2017-10156 2017-10369 2017-8437 2017-8438 2017-9355
Paediatric use of filgrastim (Neupogen) and pegfilgrastim (Neulasta) for the last 10 years for US across
2020-102 Accord Healthcare, Inc. the 6 weight bands mentioned below.
current package insert for Hospira's Epinephrine Injection, 1 mg/10 mL (NDA 209359), which received
2020-116 Salamandra, LLC Agency approval on 05 November 2019
2020-103 THE NEW YORK TIMES HHSF22301010014B
Establishment Inspection Report, Form FDA 483 and Correspondence: Texas Eye Prosthetics, LLC
2020-108 Thomson Reuters - Clarivate Analytics Houston, TX End Dates of inspection: Monday, August 12, 2019 FDA District Office: Dallas
Establishment Inspection Report, Form FDA 483 and Correspondence: Whitney Products Inc. Niles,
2020-142 Thomson Reuters - Clarivate Analytics IL End Dates of inspection: Thursday, August 22, 2019 FDA District Office: Chicago
Freedom of Information Act (FOIA): Request for Summary Basis of Approval (SBOA) of Phytonadione
2020-125 Orbicular Pharmaceutical Technologies Private Limited Injectable Emulsion USP, 1mg/0.5 mL (ANDA# 083722) by INTERNATIONAL MEDICATION SYSTEM
Establishment Inspection Report, Form FDA 483 and Correspondence: Oklahoma Blood Institute -
Sylvan N Goldman Center Oklahoma City, OK End Dates of inspection: Friday, June 07, 2019 FDA
2020-107 Thomson Reuters - Clarivate Analytics District Office: Dallas
Establishment Inspection Report, Form FDA 483 and Correspondence: HealthCare Products, Inc.
2020-141 Thomson Reuters - Clarivate Analytics Coldwater, OH End Dates of inspection: Friday, August 30, 2019 FDA District Office: Cincinnati
Establishment Inspection Report, Form FDA 483 and Correspondence: BPI Labs, Inc. Evanston, WY
2020-124 Thomson Reuters - Clarivate Analytics End Dates of inspection: Wednesday, June 12, 2019 FDA District Office: Denver
Establishment Inspection Report, Form FDA 483 and Correspondence: MATIA ROBOTICS US INC Salt
2020-123 Thomson Reuters - Clarivate Analytics Lake City, UT End Dates of inspection: Wednesday, June 05, 2019 FDA District Office: Denver
Establishment Inspection Report, Form FDA 483 and Correspondence: Rocky Mountain Research,
2020-117 Thomson Reuters - Clarivate Analytics Inc. Park City, UT End Dates of inspection: Tuesday, July 16, 2019 FDA District Office: Denver
Establishment Inspection Report, Form FDA 483 and Correspondence: Tuscano and Delucia Group
(DBA Entropic Labs) Salt Lake City, UT End Dates of inspection: Thursday, September 26, 2019 FDA
2020-115 Thomson Reuters - Clarivate Analytics District Office: Denver
Establishment Inspection Report, Form FDA 483 and Correspondence: First Call, Inc. Winona Lake,
2020-114 Thomson Reuters - Clarivate Analytics IN End Dates of inspection: Friday, July 19, 2019 FDA District Office: Detroit
Establishment Inspection Report, Form FDA 483 and Correspondence: Zetta Medical Technologies,
2020-136 Thomson Reuters - Clarivate Analytics LLC Lake Zurich, IL End Dates of inspection: Tuesday, August 27, 2019 FDA District Office: Chicago
Establishment Inspection Report, Form FDA 483 and Correspondence: Isopure Corp Louisville, KY End
2020-128 Thomson Reuters - Clarivate Analytics Dates of inspection: Monday, September 23, 2019 FDA District Office: Cincinnati
Individual case reports and narratives for the following three (3) FAERS Case IDs, reported as adverse
events for the drug tafenoquine, as listed in the following 2019 FAERS quarterly extracts: Case ID
16762057, from the 19Q3 FAERS extract Case ID 16762058, from the 19Q3 FAERS extract Case ID
2020-119 Dr. Remington Nevin 15385921, from the 19Q2 FAERS extract
2020-101 mukul sethi QUESTIONS
2020-92 NEW ENGLAND ANTI-VIVISECTION SOCIETY USE OF ANIMALS IN RESEARCH NCTR, CVM, CFSAN, CBER, CDER, ETC
Internet domain names used by Defendants in furtherance of their criminal activities, including but not
limited to re-direct Web addresses and domains; • presentations made by, or communications
with, any of the Defendants or their respective counsel to government officials, including but not
limited to the Federal Bureau of Investigation, any U.S. Attorney’s Office, and the Food and Drug
Administration; • Defendants’ monetary gain derived from their criminal activities; • data and
information underlying Defendants’ criminal conduct as it relates to the supply and sale of Gemzar®,
Cialis®, Cymbalta®, Permax®, Prozac®, Evista®, Zyprexa®, Prevacid®, Protonix®, Actos®, Daxas®, and
Atacand®, including but not limited to, all invoices, sales data (excluding names and addresses and
personal identifying information of customers, to the extent reasonable to exclude), product request
2020-120 FAEGRE BAKER DANIELS forms or correspondence, and correspondence regarding supply; ETC
All correspondences between the Secretary, FDA and the American College of Radiology ("ACR")
related to conflicts of interest for individuals conducting facility reviews for the ACR as an accreditation
2020-135 Laurie Gibbs body ETC
EIR, 483 ETC Jeron Electronic Systems Inc. Niles, IL End Dates of inspection: Thursday, June 20, 2019
2020-139 Thomson Reuters - Clarivate Analytics FDA District Office: Chicago
2020-113 Bruce C. Ransom Jr. PERSONAL EMAIL
2020-112 Bruce C. Ransom Jr. PERSONAL EMAILS
FDA contract with McKinsey & Co. for Developing Creativity and Innovation in the Center for Tobacco
2020-104 THE NEW YORK TIMES Products Office of Science, contract 75F40119F19017
2020-33 FDA NEWS Copies of Form 483s issued by the New Orleans District Office from October 1-31:
2020-49 FDA NEWS Copies of Form 483s issued by the Atlanta District Office from October 1-31:
Response to warning letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-

2020-10 Cuyahoga Falls News-Press investigations/warning-letters/sunflora-incthe-cbd-store-llc-dba-your-cbd-store-585390-11222019
Entire SBA for Revlimid (lenalidomide), NDA 021880/S-057, for the indications of adult patients with
previously treated follicular lymphoma (FL) and adult patients with previously treated marginal zone
2020-54 Genentech lymphoma (MZL), approved May 28, 2019.
All warning letters, untitled letters, Form 483s, and It Has Come to Our Attention (IHCTOA) letters
associated with the medical device Allograft GraftLink® Construct, marketed by Arthrex Inc., at 1370
Creekside Blvd., Naples, FL 34108-1945, and/or manufactured by LifeNet Health, at 1864 Concert Dr.,
Virginia Beach, VA 23453, and the outcome of any closed investigation(s) by CDRH into the Allograft
2020-73 Axinn, Veltrop & Harkrider LLP GraftLink® Construct, marketed by Arthrex Inc. and/or manufactured by LifeNet Health.
2020-31 FDA NEWS Copies of Form 483s issued by the New Jersey District Office from October 1-31:
Establishment Inspection Report, Form FDA 483 and Correspondence: Indiana University Health
2020-79 Thomson Reuters - Clarivate Analytics Indianapolis, IN End Dates of inspection: Wednesday, June 12, 2019 FDA
Entire unredacted SBA for Xofluza (baloxavir marboxil), NDA 210854, for the indication of acute
2020-65 Genentech uncomplicated influenza patients, approved October 24, 2018.
2020-55 Patrick Hamlette Jr. Emails Kathryn Vengazo January 1, 2019 to December 21, 2019
Establishment Inspection Report, Form FDA 483 and Correspondence: SpecGx LLC Saint Louis, MO
2020-81 Thomson Reuters - Clarivate Analytics End Dates of inspection: Thursday, September 12, 2019
Establishment Inspection Report, Form FDA 483 and Correspondence: Calmo Manufacturing, Inc
Huntington Beach, CA End Dates of inspection: Friday, August 23, 2019 FDA District Office: Los Angeles
2020-85 Thomson Reuters - Clarivate Analytics
Establishment Inspection Report, Form FDA 483 and Correspondence: Ajinomoto Althea, Inc. San
Diego, MO End Dates of inspection: Wednesday, August 07, 2019 FDA District Office: Los Angeles
2020-83 Thomson Reuters - Clarivate Analytics District
We request certified and authenticated copies of all Forms 3542 and Form 3542(a) filed by Bristol-
Myers Squibb or Pfizer related to U.S. Patent Nos. 6,413,980; 6,967,208; and 9,326,945 listed in the
2020-47 Karen Beckman Orange Book for NDA 202155 (RLD: Eliquis).
2020-34 FDA NEWS Copies of Form 483s issued by the Minneapolis District Office from October 1-31:
2019-586 • 2018-9266 • 2018-7047 • 2018-6919 2. Any post marketing surveillance
review from FDA OSE written on Korlym or Corlux and death or diabetes or adrenal insufficiency or
2020-4 Levi & Korsinsky, LLP weight loss. 3. All 2253 Forms related to Korlym or Corlux subject to disclosure. ETC
2020-3 FOI Services, Inc. MedWatch Reports for FAERS Case ID#s: 16508875, 16501081, 16501048
Establishment Inspection Report, Form FDA 483 and Correspondence: Vitalant Scottsdale, AZ End
2020-89 Thomson Reuters - Clarivate Analytics Dates of inspection: Wednesday, July 24, 2019 FDA District Office: Denver District
483 issued to Lantech Pharmaceuticals Limited Chittivalasa , FEI # 3012390454 for the inspection
2020-16 SCIEGEN PHARMACEUTICALS INC ending in 15 Mar 2019.
FDA's import alerts in the seafood/fisheries category FDA Notice of Actions, Notice of Import Alert,
Import Alert Removal Petitions and FDA's formal import alert removal decisions (including any
accompanying agency documents) for the following companies/import alert removals: CAB Food Sdn.
Bhd.(FEI 3009700216) from Import Alert 16-124 for shrimp and the removal of N.T. Huat Kee Fisheries
(FEI 3004689141) from Import Alert 16-124. - All FDA Notices of Action and Notices of Detention for
the following companies: CAB Food Sdn. Bhd.(FEI 3009700216), N.T. Huat Kee Fisheries (FEI
3004689141), CAB Marine Resources (FEI 3010157339), and H.K. Foods (M) Sdn. Bhd. (FEI
2020-6 InvestigateTV 3006781155)
Inspection records of Teligent manufacturing facility in Buena, NJ for inspection in May and June of
2020-43 Gregory Janetta 2019. Records requested include FDA-483, EIR, warning letter, and company responses to same.
2020-26 FDA NEWS Copies of Form 483s issued by the San Juan District Office from October 1-31:
2020-72 Sonam Mehta Form 483 for Sun pharma Halol plant catering for Human Drug.
Recent generic approvals for Fingolimod Hydrochloride Capsules (EQ 0.5 mg base) 1. A208014 -
2020-45 Strides Pharma Global Pte Limited Approval Letter 2. A207939 - Approval Letter 3. A207979 - Approval Letter
2020-27 FDA NEWS Copies of Form 483s issued by the Seattle District Office from October 1-31:
The completed version of the attached "Dietary Supplement Safety Summary Analysis," from the
Food and Drug Administration Center for Food Safety and Applied Nutrition's Office of Dietary
2020-18 CONSUMER REPORTS Supplement Programs, pertaining to Super Beta Prostate.
communication records between Senate Majority Leader Mitch McConnell and the Food and Drug
2020-19 Cannabis Wire Administration on the topic of hemp and/or cannabidiol (CBD).
2020-62 FOI Services, Inc. Signifor LAR orphan drug information.
Establishment Inspection Report, Form FDA 483 and Correspondence: Diamond Wipes International,
2020-87 Thomson Reuters - Clarivate Analytics Inc. Chino, CA End Dates of inspection: Friday, September 06, 2019 FDA District Office: Los Angeles
Establishment Inspection Report, Form FDA 483 and Correspondence: NorthStar Medical
2020-75 Thomson Reuters - Clarivate Analytics Radioisotopes, LLC Columbia, MO End Dates of inspection: Wednesday, August 14, 2019
2020-39 FDA NEWS Copies of Form 483s issued by the Cincinnati District Office from October 1-31:
2020-21 ECI Pharmaceuticals, LLC GPT Pharmaceuticals Private EIR, 483 ETC
483 issued to Repro-Med Systems, Inc. (dba RMS Medical Systems, now KORU Medical Systems)
2020-42 EMED Technologies Corporation during their 2018 Site Inspection of the Chester NY facility.
2020-35 FDA NEWS Copies of Form 483s issued by the Florida District Office from October 1-31:
Summary Basis of Approval for OXERVATETM (cenegermin-bkbj) ophthalmic solution for topical
2020-22 Andrew Mallon ophthalmic use
2020-67 Bestech GMP Contracting, Inc. Listing of drug company inspections (domestic) from 01JAN2019 - 22DEC2019
2020-60 FOI Services, Inc. Information regarding orphan drug designation for Hizentra.
2020-24 FDA NEWS Copies of Form 483s issued by the Los Angeles District Office from October 1-31:
Establishment Inspection Report, Form FDA 483 and Correspondence: Eisertech LLC San Diego, CA
2020-80 Thomson Reuters - Clarivate Analytics End Dates of inspection: Wednesday, August 21, 2019
Establishment Inspection Report, Form FDA 483 and Correspondence: The Lebanon Corporation,
2020-77 Thomson Reuters - Clarivate Analytics Inc. Lebanon, IN End Dates of inspection: Friday, June 28, 2019 FDA District Office: Detroit
2020-50 FDA NEWS Copies of Form 483s issued by the Baltimore District Office from October 1-31:
2020-9 IPAC-RS MDI characterization for new drug products and in vitro studies for product-specific guidances
This request is for .CSV files of all dated records for the below drugs, from October 2019 through today
2020-63 CITADEL INVESTMENT GROUP LLC / the latest available date, from the FDA Adverse Event Reporting System (FAERS) database.
2020-28 FDA NEWS Copies of Form 483s issued by the San Francisco Office from October 1-31:
2020-25 FDA NEWS Copies of Form 483s issued by the Kansas District Office from October 1-31:
2020-37 FDA NEWS Copies of Form 483s issued by the Denver District Office from October 1-31:
Entire unredacted SBA for Polivy (polatuzumab vedotin-piiq), BLA 761121, for the indication of adult
2020-64 Genentech patients with relapsed or refractory diffuse large B-cell lymphoma, approved June 10, 2019.
2020-1 Zydus Pharmaceuticals USA Inc. ANDA 203753
Establishment Inspection Report, Form FDA 483 and Correspondence: Protek Medical Products, Inc.
2020-84 Thomson Reuters - Clarivate Analytics Coralville, IA End Dates of inspection: Thursday, August 08, 2019
2020-12 Eminence Capital 2019-2608
Establishment Inspection Report, Form FDA 483 and Correspondence: SSM Health Care St. Louis
DBA SSM St. Clare Health Center Fenton, MO End Dates of inspection: Wednesday, August 28, 2019
2020-82 Thomson Reuters - Clarivate Analytics FDA District Office: Kansas City
Entire unredacted SBA for Rozlytrek (entrectinib), NDA 212725, 212726, for the indication of adult
patients with non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive and adult and
2020-59 Genentech pediatric patients with NTRK gene fusion solid tumors, approved August 15, 2019.
2020-52 FDA NEWS Copies of Form 483s issued by the CDER Office from October 1-31:
2020-40 FDA NEWS Copies of Form 483s issued by the Chicago District Office from October 1-31:
2020-38 FDA NEWS Copies of Form 483s issued by the Dallas District Office from October 1-31:
2020-36 FDA NEWS Copies of Form 483s issued by the Detroit District Office from October 1-31:
2020-48 Andersen Pharma LLC NDA 007513, LEVOPHED reviews of a) Summary Review b) Chemistry Review(s)
RLD prescribing information of “KLOR-CON M10, KLOR-CON M15 & KLOR-CON M20”. We need
current RLD prescribing information labeling to revise our proposed generic labeling in the ANDA
2020-15 Granules Pharmaceuticals Inc. submitted to the Agency.
2020-8 Mankind Pharma Limited NDA APPROVAL RECS
Establishment Inspection Report, Form FDA 483 and Correspondence: Thermo Fisher Scientific dba
2020-78 Thomson Reuters - Clarivate Analytics Patheon Biologics LLC Saint Louis, MO End Dates of inspection: Friday, August 02, 2019
Establishment Inspection Report, Form FDA 483 and Correspondence: Henry Ford Hospital Detroit,
2020-76 Thomson Reuters - Clarivate Analytics MI End Dates of inspection: Friday, July 19, 2019 FDA District Office: Detroit District Decision: VAI
Meeting minutes and briefing documents from FDA meetings between Provention Bio and the FDA
2020-69 WJ Sonnier, LLC regarding the drug teplizumab.
483 for the inspection carried out at R.L. Fine Chem Private Limited , Bengaluru ending in 22 Feb ,
2020-13 SCIEGEN PHARMACEUTICALS INC 2019
2020-29 FDA NEWS Copies of Form 483s issued by the Philadelphia District Office from October 1-31:
Requesting as counsel of Revival Animal health, on behalf of Revival Animal Health, to ensure
completeness of records regarding regulatory inspections and compliance. Please provide all
information related to FDA audits and inspection records for the facility at 1700 Albany Pl Se, Orange
City, IA 51041-9680, including correspondence regarding potential enforcement actions or any
2020-23 McKee Voorhees & Sease warnings.
Any documents Philip Morris has provided the FDA regarding the labelling, advertising, marketing
plans, and target audiences for its iQOS and Heets products. Documents detailing Philip Morris’ plans
to restrict youth access and limit youth exposure to the products’ labelling, advertising marketing and
2020-20 The Bureau of Investigative Journalism promotion ETC
2020-7 Murphy, Falcon & Murphy P.A. Spinal Solutions, LLC and/or Orthopedic Alliance, LLC INVESTIGATION RECS
2020-5 FOI Services, Inc. Inspection information for Instituto Bioclon, Mexico City, Mexico.
The contact details of all companies involved in the manufacture of cosmetic in the United States and
2020-68 Jessica Jenkins registered in the VCRP " Voluntarily Cosmetic Registration program
2020-46 Andersen Pharma LLC NDA008845, QUELICIN CMC review(s) or Chemistry review
2020-66 FOI Services, Inc. Prograf orphan drug designation information.
2019-12076 Tess Knizek history, pharmacology, and efficacy of CBD as a treatment for medical conditions
483 issued to Repro-Med Systems, Inc. (dba RMS Medical Systems, now KORU Medical Systems)
2019-12074 EMED Technologies Corporation during their 2019 Site Inspection of the Chester NY facility.
The contact details of all companies involved in the manufacture of cosmetic in the United States and
2019-12075 Jessica Jenkins registered in the VCRP " Voluntarily Cosmetic Registration program
The agreement (Contract No. HHSF223201610004B) between the FDA and Aurotech Inc. including
related request for proposal (RFP), proposal, change orders, amendments or similar ancillary
documents. In addition, documents showing amounts obligated and spent in connection with that
2019-12064 Global Immigration Partners agreement.
Facility Inspection Records: Spinal Solutions, LLC FEI 3004884943 Murietta, California Orthopedic
Alliance FEI 3004022256 Murietta, California Please include communication from and to the
2019-12061 Murphy, Falcon & Murphy P.A. establishments and the FDA regarding the facility inspections.
e-mails from October 24, 2019 that include Michael Felezzola in the To; From; and Cc'd sections of the
2019-12054 Patrick Hamlette Jr. email header.
2019-12049 Patrick Hamlette Jr. JUSTIN GREEN EMAILS
MTGS BTWN ACTING COMMISSIONER BRETT GIROIR AND DAVID HALLAL, EDWARD MILLERS, JUAN
2019-12048 American Oversight VERA, ETC 11/1/19 TO 12/17/19
ETHICON - ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP
2019-12056 HAYES LORENZEN LAWYERS PLC WARNINGS, MDRS, RECALL NOTICES, ETC
Sunshine Mills, Inc. manufacturing facility in Tupelo, Ms. 483, the written responses, and any other
documentation pertaining to the inspection, which was caused by elevated levels of vitamin D in the
2019-12046 THE WASHINGTON POST dog food
2019-12038 FDA NEWS A listing of all FDA Form 483 Notices of Inspectional Observations
All tobacco product problem reports submitted to FDA related to products distributed by Logic
Technology Development, including but not limited to Logic Power, Logic Pro, Logic VapeLeaf and
Logic LQD. Such reports should include, but not be limited to, reports about products that are
2019-12033 TROUTMAN SANDERS LLP damaged, defective, contaminated, smell or taste wrong, or cause unexpected health effects.
Looking for FDA 90 day facility classification decisional letter for Shire Human Genetic Therapies, Inc.
2019-12044 TAKEDA AMERICA INC EIN 3009340644 Lexington, MA
2019-12039 Dragonberry Produce Inc. LAB request for ENTRY 9GK-0070366-4 FULL ANALYSIS LAB Package
records, including test results, documents, and written responses related to Form 483, issued by the
FDA to Hill's Pet Nutrition whose facility is located in Emporia, Kansas in response to their Vitamin D
recall. Hill's Pet Nutrition provided the FDA with written responses dated March 12, May 23 and
2019-12047 THE WASHINGTON POST August 30, 2019.
Inspection Report for Almac Clinical Services, LLC. located in Durham NC 27704 USA with inspection
2019-12006 BAVARIAN NORDIC end date 06/08/16
2019-12017 SunOpta Inc. Consumer complaint investigation report, reference number 159606
Docket number 80N-0042 Anticaries drug products for over-the-counter use. OTC volumes 080018,
080019, and 080127 found in reference (15) on page 20685 of Volume 45, number 62 of the Federal
Register published on March 28, 1980. This is information pertaining to caries clinical trials performed
2019-12005 PROCTER & GAMBLE with a stannous fluoride-containing toothpaste.
2019-11999 CONSUMER REPORTS CAERS report #s: 2018-CFS-008213, 180321, 184674, 185673
The Form 483 and EIR issued to TruVision Health LLC, pertaining to an inspection that was completed
2019-11998 CONSUMER REPORTS on 5/31/2017 for a facility located in Draper, UT 84020, United States.
2019-12019 SHAHEEN & GORDON INDIVIDUAL RECS
2019-12007 SunOpta Inc. Collection report and analytical worksheet for sample 1117863
FDA report regarding Midwest Northern Nut of Minneapolis, MN voluntary recall concerning
2019-12015 WAYMOUTH FARMS INC undeclared allergens, FDA initial publish date on March 11, 2018.
2019-12003 FDAAWARE 3 separate CDs (or folders) all 483s. EIRs and 483 responses for the above period.
2019-11982 FRITZ & BIANCULLI LLC CAERS - 216444, 2166629, 013295, 178574, 94700, 109150
2019-11973 Kozyak Tropin & Throckmorton, P.A. ELMIRON NDA 020193 6/11/91
2019-11979 NANCY TEMKIN DEVILBISS HEALTHCARE TRANSFER TUB BENCH - AER 2011 TO PRESENT
correspondence with FDA (emails, inspection reports, etc) on Enchanted Acres Farms located at 200 N
2019-11962 Jeanne Hoskin 8th St Reading, PA 19601-4102, registration, etc
correspondence with FDA (emails, inspection reports, etc) on Enchanted Acres Farms located at 200 N
2019-11962 Jeanne Hoskin 8th St Reading, PA 19601-4102, registration, etc
2019-11976 BHAN KANOM THAI ENTRY NO 442-8820958-6
For the date January 1, 2018 to the present date, I request a copy of all documents and
communications (including emails, letters, reports, presentations, handouts, pamphlets, and other
materials) relating to “online pharmacies”, “personal drug importation”, the “National Associations of
Boards of Pharmacy”, “NABP”, “.pharmacy”, “VIPPS”, “Not Recommended Sites”, “NRL”,
“VeifyBeforeYouBuy.org”, or “PharmacyChecker”, between any FDA office, department, staff, or
representative and any of the following parties: 1. Microsoft 2. Google 3. Facebook 4. The National
Association of Boards of Pharmacy or NABP 5. The Center for Safe Internet Pharmacies or CSIP 6.
Libby Baney 7. The Alliance for Safe Online Pharmacies or ASOP 8. LegitScript 9. The
2019-11954 PharmacyChecker.com, LLC Partnership for Safe Medicines or PSM
2019-11989 University of Gothenburg Effexor (venlafaxine, NDA 20151) clinical reviews for
2019-11896 Sonika Shinghal 2019-10774
POSITION DESCRIPTION FOR FDA MENTORING PROGRAM MANAGER GS13 LEWIS FRANCIS 11/1/15
2019-11919 BRUCE C RANSOM JR TO12/6/19
Letters from the U. S. Food and Drug Administration (FDA) stating that the processes for the
manufacture of vanillin as submitted to FDA for the products that are specifically identified below have
been determined to be natural processes. Solvay SA/Rhodia Operations for their product Rhovanil ®
Natural Xiamen Bestally Biotechnology Co., Ltd for their product Bestvanil Advanced Biotech for their
2019-11897 BASF - The Chemical Company products ABTVanforall and ABTVanforall Plus
Device Classification Name: System, Imaging, Optical Coherence Tomography (Oct) 510(K) Number:
K123369 Device Name: ILUMIEN OPTIS Applicant: LIGHTLAB IMAGING, INC. 4 ROBBINS ROAD
2019-11937 Spectrawave Westford, MA 01886
Device Classification Name: Catheter, Intravascular, Diagnostic 510(K) Number: K141453 FOIA
Releasable 510(K): K141453 Device Name: ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER
2019-11935 Spectrawave Applicant: LIGHTLAB IMAGING, INC. 4 ROBBINS ROAD Westford, MA 01886
2019-11908 FOI Services, Inc. K072113, Integra Flowable Wound Matrix
2019-11939 INTERNATIONAL COSMETICS & REGULATORY SPECIALISTS LLC GUIDELINES FOR EFFECTIVENESS TESTING OF ANTIPERSPIRANT DRUG PRODUCTS
Daily inspection reports of the inspectors who visited Sparboe Farms, Ltd. , an egg processing/packing
located in Litchfield, Minnesota, with the LEGAL MAILING ADDRESS 23577, Minnesota Hwy 22 #961,
2019-11923 Teri Bentson Litchfield, MN 55355.
ELMIRON (PENTOSAN POLYSULFATE SODIUM) NDA 20-193 - ISRS 16343089, 16298711, 15678737,
2019-11888 LEVIN PAPANTONIO THOMAS ET AL ETC; POSTMARKETING SUVEILLANCE RVWS 1/1/16
2019-11892 Altria Client Services JOHN MIDDLETON CO - SUBSTANTIAL EQUIVALENCE RPTS SE0015206
ENFORCEMENT PRIORITIES FOR ELECTRONIC NICOTINE DELIVERY SYSTEMS (ENDS) AND OTHER
2019-11876 BuzzFeed NEws DEEMED PRODUCTS ON THE MARKET WITHOUR PREMARKET AUTHOIZATION
2018-5116, 2018-5908, 2018-6156, 2018-6156, 2018-7288, 2018-8118, 2018-8255, 2018-8472, 2018-

8921, 2019-10169, 2019-10276, 2019-10282, 2019-10287, 2019-10288, 2019-10293, 2019-10342,
2019-10472, 2019-10473, 2019-10474, 2019-10648, 2019-10649, 2019-10657, 2019-11111, 2019-
2019-11859 CONSUMER REPORTS 11259, 2019-11300, 2019-11307, 2019-7027, 2019-11311, 2019-7266, 2019-9384
2019-11893 PAUL SMITH B64568 ZANTAC - AER
LIST OF SUMMARY INFORMATION OF ESTABLISHMENT INSP FOR MANUFACTURERS OF APIs 1/1/15 TO
2019-11883 RON SCHWARZ PRESENT
Enforcement Reports on its website
(http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm) identifying all recalls
2019-11844 Registrar Corp monitored by FDA once they are classified according to the level of hazard involved.
All Food and Drug Administration (FDA) documents related to California-based BioCorRx, Inc.,
including but not limited to all correspondence between the FDA and BioCorRx, as well as any other
2019-11828 PUBLIC CITIZEN emails, letters, reports, and memoranda.
Copies of all FOIA request made to the Food and Drug Administration regarding the Karoun Dairies,
2019-11849 Faegre Baker Daniels LLP Inc., 2015 Listeria Outbreak
All internal presentations created by the FDA from 2012 until present regarding the following Mylan
Pharmaceutical Manufacturing Facilities, and any observed cGMP compliance issues: o Mylan Unit 3
(FEI No. 3003937580) o Mylan Unit 8 (FEI No. 3002785310) o MLL – Aurangabad (FEI No. 3008316970)
2019-11832 KANNER & WHITELEY LLC o MLL – Nashik (FEI No. 3005587313) o MPI – Morgantown (FEI 1110315)
unredacted copies of Food Contact Notification (FCN) 2001 review memoranda and all related
2019-11826 Keller and Heckman LLP documentation.
2019-11825 THE WASHINGTON POST All correspondence, memos, briefs and meeting notes regarding NDA-610 and NDA-611.
A list of all inspections conducted by former FDA inspector and chemist Zi-Qiang Gu from 2000 to
2019-11839 KANNER & WHITELEY LLC present.
correspondences of GRN 677 for docosahexaenoic acid oil produced in Schizochytrium sp. and GRN
2019-11856 Nutrasource Diagnostics Inc. 777 for algal (55% docosahexaenoic acid) from Schizochytrium sp. strain FCC-3204.
2019-11848 Northeastern University FDA Summary Review of supplement 12 for the drug Xifaxan (Rifaximin)
Records of any investigation, audit or inquiry relating to surgical hip and knee devices distributed
and/or sold by Orthopedic Alliance, LLC (a California limited liability company) and/or its owners Roger
2019-11818 Sheppard Mullin Richter & Hampton LLP, Attn Barbara Taylor Williams and Mary S. Williams.
Occupational Safety and Health Administration's recent testing of talc samples performed at the U.S.
2019-11806 THE WALL STREET JOURNAL Food and Drug Administration's request, including any tests of Johnson's Baby Powder
2019-11790 Center for Science in the Public Interest CAERS case narratives referencing confirmed or suspected allergic reaction to sesame
A summary list of all Decision Letters issued by the FDA's Division of Import Operations in response to
Import Alert Removal Petitions, from Jan. 1, 2015 until the day this request is processed, including
2019-11816 CONSUMER REPORTS whether or not the removal petition was approved or not.
Any and all information and/or records relating to cat food sold by J.M. Smucker Company (fka Big
Heart Pet Brands) under the brand names 9Lives®, EverPet, Special Kitty, and or any other brand
2019-11796 Wegman Hessler name.
(1) Please provide the number of GMP inspections by the FDA in pharmaceutical manufacturing
plants in India for each month during the calendar years 2016, 2017, 2018, and so far in 2019. (2)
Please provide the number of surprise GMP inspections by the FDA in pharmaceutical manufacturing
2019-11805 REUTERS plants in India for each month during the calendar years 2016, 2017, 2018, and so far in 2019.
• Any communications between the FDA and Smucker, their suppliers, representatives, agents,
and/or employees related to the December 5, 2019, recall of Special Kitty wet cat food manufactured
2019-11795 LOCKRIDGE GRINDAL NAUEN PLLP by Smucker (the “Recall”); etc
FOIA requests filed with FDA's Center for Food Safety and Applied Nutrition (CFSAN), including related
2019-11803 Public Health Law Center, Inc offices, from 01/01/2019 to 12/9/2019.
2019-11754 KCI USA, INC. K033523
2019-11755 KCI USA, Inc. K014129
2019-11782 TRUTH ABOUT PET FOOD JM SMUCKER PET FOOD - RECALL 483, CORR 12/5/19
Please provide copy of the 483 and EIR for the inspection conducted 11/12/19 to 11/22/19:
2019-11767 Alnylam Pharmaceuticals - Ken Howerton Ajinomoto (Althea) 11040 Roselle St. San Diego, CA 92121
2019-11753 Underwood Fruit and Warehouse FSMA Produce Safety Inspections that occurred in Oregon during the fiscal year of 2019.
2019-11768 FOI Services, Inc. Approval Letters and Labeling for Toradol .
2019-11750 Baptist Health Paducah test results
2019-11748 Hyman, Phelps & McNamara, P.C. WAYNE HELLSTROM, NEW ORLEANS - EIR
2019-11776 Harrington Films EMAILS FROM CECILIA WOLYNIAK 11/19
2019-11730 FDA NEWS Copies of Form 483s issued by the Detroit District Office from October 1-31:
2019-11733 FDA NEWS Copies of Form 483s issued by the Chicago District Office from October 1-31:
2019-11728 FDA NEWS Copies of Form 483s issued by the Kansas District Office from October 1-31:
2019-11741 FDA NEWS Copies of Form 483s issued by the Baltimore District Office from October 1-31:
2019-11695 United Safety Agents LLC Records for which the FSVP Importer’s UFI or DUNS is 08-08-01169 etc
2019-11739 FDA NEWS Copies of Form 483s issued by the CDER Office from October 1-31:
2019-11723 FDA NEWS Copies of Form 483s issued by the San Francisco District Office from October 1-31:
1. Any and all correspondence exchanged between the FDA and Stanley Brothers Social Enterprises,
LLC (“Stanley Brothers”) regarding and/or relating to the Warning letter issued to Stanley Brothers,
2019-11710 Couch White, LLP dated October 31, 2017 ETC
2019-11719 FDA NEWS Copies of Form 483s issued by the New Jersey District Office from October 1-31:
2019-11724 FDA NEWS Copies of Form 483s issued by the Minneapolis District Office from October 1-31:
2019-11742 FDA NEWS Copies of Form 483s issued by the Atlanta District Office from October 1-31:
2019-11727 FDA NEWS Copies of Form 483s issued by the Dallas District Office from October 1-31:
Any and all records, including, without limitation, ledgers, balance sheets, synopses of invoice
payments to any party, pertaining to all Center for Tobacco Products (CTP) expenditures or expenses,
grants, donations, marketing expenses, travel, conferencing and any other use of the funds collected
by CTP through user fees during the relevant time period, as well as any record indicating any unspent
2019-11711 RegulationStrategy CTP user fees carried over as a surplus during the relevant time period.
2019-11720 FDA NEWS Copies of Form 483s issued by the New England District Office from October 1-31:
2019-11718 FDA NEWS Copies of Form 483s issued by the New Orleans District Office from October 1-31:
2019-11726 FDA NEWS Copies of Form 483s issued by the Los Angeles District Office from October 1-31:
list of all citizen petition filings with CFSAN since 2000, preferably in Excel or CSV format if stored in
2019-11691 Public Health Law Center that format
2019-11732 FDA NEWS Copies of Form 483s issued by the Cincinnati District Office from October 1-31:
the Letter of Designation issued by the Office of Combination Products (OCP) in response to Alliqua
BioMedical, Inc.’s Request for Designation (RFD) regarding its Interfyl product, a decellularized
particulate human placental connective tissue matrix intended to replace or supplement damaged or
2019-11653 Hogan Lovells inadequate integumental tissue.
2019-11633 TARA S THOMAS GULF COAST VETERANS HEALTH CARE SYSTEM, BILOXI, MS - EIR 11/27-18/18
2019-11661 Dhan AI 2019-1652 2019-2235 2019-6519 2019-6520
establishment inspection report for facility inspection from 9/11/2019 to 9/13/2019-The New French
2019-11652 Rise Baking Company LLC dba The New French Bakery Inc. Bakery
2019-11631 FANNIN LITIGATION GROUP PS M-COR MODULAR HIH SYS K053417 - EMAILS, RECS
2019-11669 FDAZILLA Beverly A Thomas, Alison N Stieg, Eias A Zahalka, Bapu R Gaddam, ETC CVS
Mitch Zeller, Director of the Center for Tobacco Products ETC EMAILS RE “British American
2019-11670 Lisa Swanson Tobacco” January 1, 2016
FDA decisions issued from 2014 to present involving products composed of or containing amniotic
tissue, chorionic tissue, or umbilical cord tissue: (1) Letters of Designation issued by the Office of
Combination Products (OCP) in response to Requests for Designations (RFDs); (2) preliminary
2019-11655 Hogan Lovells assessments issued by OCP in response to pre-RFDs
Any and all reports centered on the Sweet Springs Valley Water Company, a bottled water
manufacturer based in Monroe County, West Virginia. Any documents held by the FDA regarding
inspections performed at the Sweet Springs Valley Water Company water bottling plant, in Monroe
2019-11627 The Charleston Gazette-Mail County, West Virginia.
The response from NAC Marketplace Company to the FDA's Form 483 issued for Inspection #981270,
for an inspection that was completed on Aug. 5, 2016. The location of the inspection facility is: 95
2019-11616 CONSUMER REPORTS Executive Drive, Suite 14, Edgewood, NY 11717
RE: Darling Ingredients Inc., Newark, NJ. Please provide Form(s) 482, Form 483 (if issued),
Establishment Inspection Report and any Warning Letters, Untitled Letters, consumer complaints, lab
results, or other prior or subsequent correspondence or communications relating to the inspection of
2019-11622 eFoodAlert this location completed 09/04/2019.
2019-11592 Vanda Pharmaceuticals, Inc NDA 205677/S-004 MEDICAL RVW
• Form FDA 483 record(s) for any and all inspection’s that took place at CoreRx Inc's manufacturing
facilities located in Clearwater, Florida from January 2017 to present. • List of inspections,
corresponding dates, and classifications (VAI/NAI/OAI) for that same facility not otherwise listed in the
2019-11565 DEERFIELD INSTITUTE FDA Inspection Classification Database
1. All Inspection reports (Form 483s) for all FDA inspections of manufacturing facilities for McGhan
Medical, Inamed and Allergan breast implants. These were manufactured in Ireland, Santa Barbara,
2019-11555 David Randolph Smith & Associates CA, and Costa Rica.
2019-11597 CAMPAIGN FOR TOBACCO-FREE KIDS RIN 0910-ZA56 DOCS
Medical Device Establishment Inspection Reports for Allergan Textured Saline and Silicone Breast
2019-11552 Bentley and More LLP Implant Facilities
2019-11594 ALSTON & BIRD CONAGRA BRANDS INC - PARKAY SPRAY LBLG 9/6/19
2019-11561 IPD ANALYTICS LLC 10/23/19 tentative approval letter for ANDA No. 211030 for Calcitriol etc
2019-11578 Affimed GmbH Patheon Italia etc EIR
food and beverage recalls with classification dates between 1/1/2019 and 12/31/2019: Product Type,
2019-11550 U.S. Public Interest Research Group Education Fund, Inc. Recall Event, Initial Firm Notification of Consignee or Public, Recall Number, etc
A summary of annual inspections completed by the FDA of any and all dietary/herbal supplement
2019-11575 CONSUMER REPORTS manufacturing facilities from 2004-2019.
2019-11567 FOI Services, Inc. 13 MedWatch Reports.
Form FDA 483 and Correspondence: Cosmedical Technologies, LLC Davie, FL, USA End Dates of
2019-11517 Thomson Reuters - Clarivate Analytics inspection: Friday, March 22, 2019
We are requesting a listing of all entities, commercial and personal, that have requested a FOIA copy
2019-11521 Keller and Heckman LLP of Food Contact Notification (FCN) 1835.
2019-11513 Gutride Safier LLP RECS RE PETER THOMAS ROTH LABS
We respectfully request a copy of the Establishment Inspection Report and all supporting
documentation and inspection records for the following facility: Vital Pharmaceuticals, Inc., d/b/a VPX
2019-11540 Vital Pharmaceuticals, Inc. Sports 1600 North Park Drive Weston, FL 33326
All form FDA-483 correspondence, Establishment Inspection Reports and 510k submission(s) and
communications relating McGhan Medical, Inamed, Allergan breast implants and any other
information regarding investigation of BIA-ALCL, lymphoma or ALCL.These facilities were in Ireland,
Costa Rica and Santa Barbara CA. The 510 K would be in 1988 or 1989 when McGhan Medical
2019-11504 David Randolph Smith & Associates introduced the Biocell textured implant to the market.
All form FDA-483 correspondence, Establishment Inspection Reports and 510k submission(s) and
communications relating McGhan Medical, Inamed, Allergan breast implants and any other
information regarding investigation of BIA-ALCL, lymphoma or ALCL.These facilities were in Ireland,
Costa Rica and Santa Barbara CA. The 510 K would be in 1988 or 1989 when McGhan Medical
2019-11504 David Randolph Smith & Associates introduced the Biocell textured implant to the market.
2019-11496 COUNTRY LIFE LLC ABH NATURE'S PRODUCTS, BRENTWOOD, NY - EIRS, 483S 1/16 TO PRESENT
The Orphan Designation records for tocilizumab, which was designated on 07/31/2012, and any
related non-confidential correspondence between the sponsor (Genentech, Inc.) and the Office of
2019-11466 Tremeau Pharmaceuticals, Inc. Orphan Product Development.
2019-11497 SBCR CONSULTING LLC GAMUNEX - APRVL RECS, SBA
Invitrx Therapeutics Jun 2018 Inspection 27 Mauchly
Ste 200 Irvine, CA, 92618-2333
The U.S. Food & Drug Administration (FDA) audited the Invitrx Therapeutics
facility in Irvine, CA, United States in Jun 2018. This inspection ended on 6/13/2018.
2019-11479 Brittany Ogilvie
Pursuant to the Freedom of Information Act, 5 U.S.C. Section 552 et seq.("FOIA"), I request access to
and copies of all documents and records obtained by the Food and Drug Administration from Juul Labs
Inc. as part of the agency’s inspection of the company during the months spanning June 2018 to
2019-11451 BLOOMBERG NEWS December 2018
Invitrx Therapeutics Sep 2016 Inspection 27 Mauchly
Ste 200 Irvine, CA, 92618-2333
The U.S. Food & Drug Administration (FDA) audited the Invitrx Therapeutics
facility in Irvine, CA, United States in Sep 2016. This inspection ended on 9/26/2016.
2019-11480 Brittany Ogilvie
2019-11391 Lennham Pharmaceuticals Inc. Generally Recognized as Safe (GRAS) notice for caffeine, GRN 347.
2019-11450 FDAZILLA 2017-7914, 2018-2850, 2018-3532, 2018-4026, 2018-6909
Information submitted for post consumer recycled plastic for food contact. Specifically, analytical
chemistry data submitted as part of the challenge test for recycled polyolefins (PCR) from KW Plastics:
PNC #1317/PCR web reference #169 Polyethylene, NOL Sept 20, 2013 AND KW Plastics PNC
2019-11426 Societie des Produits Nestle #1398/PCR web reference #178, NOL July 1, 2014
2019-11388 ABC NEWS A list of DoD priority programs that have received “breakthrough therapy designation.” etc
2019-11424 SCIENCE MAGAZINE KEITH AQUA MD, BOYNTON BEACH, FL ETC - 483, EIR ETC
Import data on all human drugs, vaccines, or active pharmaceutical ingredients (API) intended for use
in human pharmaceuticals imported to the USA from any foreign country between Jan 1 1980 to
present including information on type of human drug, vaccine, or pharmaceutical ingredient imported,
2019-11370 Jessica Craig volume or amount imported, etc
All records concerning cases, diagnosis, and research over the recent confirmed lung disease cases and
their relations to vaping nicotine and THC products. Research/scientific documents related to vaping
and lung disease. The ages of the individuals affected by the recent surge in lung disease cases. The
incident reports, FDA Actions, Preliminary Lab Analysis, and information for consumers, health care
2019-11358 Southeastern Oklahoma State University providers, and state health departments.
510k submission package of K142988 Sleepware G3
2019-11339 BioIntellisense Inc. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142988
I would like to request the original submission and the environmental impact decisions for FCN
notifications of FCN no.1857, an aqueous solution of hydrogen peroxide (CAS Reg. No. 7722-84-4),
aluminum nitrate, nonahydrate (CAS Reg. No. 7784-27-2), and phosphoric acid (CAS Reg. No. 7664-38-
2019-11321 Nutrasource Diagnostics Inc. 2), with the effective date of Feb 24, 2018.
I would like to request the original submission and the environmental impact decisions for FCN
notifications of FCN no.1790, phosphoric acid, iron (2+) salt, (2:3:x) (CAS Reg. No. 14940-41-1
2019-11317 Nutrasource Diagnostics Inc. (anhydrous); (CAS Reg. No. 10028-23-6) (octahydrate), with the effective date of Aug 3, 2017.
(5) individually-certified copies of the October 18, 1999 Brief Description of the Caveats of System
2019-11306 COGENCY GLOBAL INC. from the Adverse Event Reporting System (AERS) Office of Postmarketing Drug Risk Assessment.
(5) individually-certified copies of the complete transcript of the September 3, 1992 Gastrointestinal
2019-11305 COGENCY GLOBAL INC. Drugs Advisory Committee meeting.
(5) individually-certified copies of the Minutes from the May 24-25, 1990 Gastrointestinal Drugs
2019-11304 COGENCY GLOBAL INC. Advisory Committee Meeting
2019-11303 THE PROCTER & GAMBLE COMPANY K860737
(5) individually-certified copies of the July18, 2005 Brief Description of the Caveats of System from the
2019-11299 COGENCY GLOBAL INC. Adverse Event Reporting System (AERS) Office of Pharmacoepidemiology and Statistical Science
(5) individually-certified copies of the December 4, 2014 “Content and Format of Labeling for Human
2019-11298 COGENCY GLOBAL INC. Prescription Drug and Biological Products: Requirements for Pregnancy and Lactation Labeling”
2019-11291 RT WHOLESALE, LLC DBA: FOOD EVOLUTION RT WHOLESALE, INC, SCHILLER PARK, IL, DALLAS, TX - FORM 483 ETC
COMMUNICATIONS BTWN PLOOM INC AND THE CENTER FOR TOBACCO PRODUCTS 1/1/09 TO
12/31/14; COMMUNICATIONS BTWN PAX LABS INC AND THE CENTER FOR TOBACCO PRODUCTS
2019-11284 MUCKROCK NEWS 1/1/15 TO 12/31/16, ETC
All files, reports, follow up materials, references to other agencies, and any other related materials
such as form 483 regarding the inspections of: 1) LA Ejuice LLC dba Five Star Juice in Torrance CA
2019-11245 BLOOMBERG NEWS 2)Electric Lotus, LLC in Redlands CA 3) Artist Liquid Laboratories LLC in Monroe WA
All files, reports, follow up materials, references to other agencies, and any other related
2019-11244 BLOOMBERG NEWS materials including form 483 regarding the inspection of Elite Vapor of Tennessee in Jackson TN
All files, reports, follow up materials, references to other agencies, and any other related materials
2019-11243 BLOOMBERG NEWS including form 483 regarding the inspection of Chuckin' Clouds Vape Shop Inc. in Poplar Bluff Mo.
2019-11199 Pavneet Singh FDA EMPLOYEE INFORMATION
2019-11185 CORK SUPPLY PORTUGAL FCN 1975; 2002
A copy of the clinical trial report submitted to FDA by Merck for NCT00092547 (A Study of Gardasil
(V501) in Preadolescents and Adolescents (V501-018) available at:
2019-11182 Informed Consent Action Network https://www.clinicaltrials.gov/ct2/show/study/NCT00092547?term=nct+00092547&rank=1).
records regarding the use of ketamine in comparison and in conjunction with haloperidol, propofol,
2019-11173 University of St. Thomas Law School- Community Justice Project and midazolam in cases of pre-hospital agitation and sedation.
AMENDMENTS TO THE LIST OF BULK DRUG SUBSTANCES THAT CAN BE USED TO COMPOUND DRUG
2019-11164 KENNETH V HEMMERLE II ATTORNEY PRODUCTS
All correspondence between the FDA and the Bureau of Prisons (BOP) regarding the BOP's execution
2019-11137 REUTERS protocol(s); etc
483 inspection reports or warning letters, for Alternative Ingredients facilities in the Greensboro,
2019-11114 BLOOMBERG NEWS North Carolina
Briefing materials on feasibility of state-level plans, in Florida and elsewhere, to import
2019-11104 CBC NEWS pharmaceuticals from Canada and other countries.
NVS Zolgensma cases # 16712898, 16768003, 16781215, 16778437, 16692282, 16744262, 16682408,
2019-11035 Point Seventy Two 16646203, and 16526909.
Establishment Inspection Report for Pfizer Inc, Pearl River, NY 10965 for the Vaccine Manufacturing
2019-11027 Dominick DiPaolo area from October 14, 2014 to October 31, 2014.
FDA application review files for Emgality's supplement for the indication for the Treatment of Cluster
2019-11007 Teva Pharmaceuticals Headache that was approved on June 4,2019
FDA application review files for Emgality's supplement for the indication for the Treatment of Cluster
2019-11007 Teva Pharmaceuticals Headache that was approved on June 4,2019
2019-10996 MAGLIO CHRISTOPHER & TOALE LAW FIRM INDIVIDUAL RECS
We would like to see all available historical adverse event reporting that is available for the following
products: SRP-9001 (Sareta Therapeutic's DMD gene therapy product), SGT-001 (Solid Bioscience's
2019-10974 Scopia Capital DMD gene therapy product), and PF-06939926 (Pfizer's DMD gene therapy product).
2019-10953 SharpRx Pharmaceutical Consultation Services, INC I am seeking a copy of the original BLA approval letter for Imogam Rabies Vaccine
materials related to the orphan drug designation and exclusivity for Sublocade (buprenorphine HCl),
2019-10937 FOI Services, Inc. by Inidivior, which was approved for marketing on 11/30/2017
2019-10914 FDAZILLA EIR for Human Drugs inspection of Celerion Inc. ending 06/05/2019 at the location in Tempe AZ ETC
Food Additive Petition (FAP) 797 regarding xylitol. This FAP and substance, first listed in 27 Fed. Reg.,
5098 (May 30, 1962), was filed by Lorenz and Lihn GmbH, Bad Godesberg-Mehlem, Federal Republic
2019-10910 Keller and Heckman LLP of Germany.
2019-10901 Layla Ilchi data records for consumer complaints on Allergan’s Botox treatment
2019-10867 Elanco US, Inc tulathromycin tissue regulatory method
INSTITUTE OF PHARMACOLOGICAL SCIENCES OF SOUTHERN

2019-10860 SWITZERLAND ERENUMAB - ISRS 16397506, 16258622, 16443096, ETC
FDA's official meeting minutes from Histogenic's pre-Investigational New Drug (IND) meeting
2019-10833 UNIVERSITY OF CALIFORNIA IRVINE regarding Neocart.
NDA/BLA number, the NDA and BLA approval date (including efficacy supplements), molecule name,
2019-10825 Precicion Health Economics and approved indication
2019-10810 AKIN GUMP ET AL NEMBUTAL; PENTOBARBITAL; PENTOBARBITAL SODIUM; ETC - IMPORTS
2019-10806 Baker Hostetler DOCKET FDA-2018-N-3240 CUSTOPHARM INC
COMPANY: Sinclair Research Center ADDRESS: 562 State Road DD CITY< STATE AND ZIP: Auxvasse,
2019-10789 Zoetis Inc. MO 65231 REQUEST INFO: FDA 483; FDA GLP Inspections; EIR; All Inspections
COMPANY: Southwest BioLabs, Inc ADDRESS: 401 N. 17th Street, Suite #11, LAS Cruces, NM REQUEST
2019-10787 Zoetis Inc. INFO: AnyFDA 482; FDA 483; FDA GLP Inspections; EIR; All Inspections
All presentations from "U.S. Food and Drug Administration Part 15 Hearing - November 4, 2019 Use
2019-10749 Kyle Larson of Fecal Microbiota for Transplantation to Treat Clostridium difficile"
2019-10726 Informa / Natural Products Insider records related to new dietary ingredients and FDA's responses to them in the fiscal year 2019.
The Post Market Data Assessment (PMDA) report (including any attachments and supplements to the
report) concerning the facility operated by Torrent Pharma Inc. at 2091 Hartel Street, Levittown,
2019-10721 KING & SPALDING Pennsylvania 19057, FEI Number 3004536846.
Slides for the Joint Meeting of the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC)
2019-10714 FOI Services, Inc. and Oncologic Drugs Advisory Committee (ODAC).
2019-10685 Hyman, Phelps and McNamara RECS RE USE OR PROPOSED USE OF MILK FAT GLOBULE MEMBRANE IN INFANT FORMULA
Date Range: 01/01/2019 - 10/30/2019; Any literature reviews or analyses related to Nicotine or
2019-10650 JUUL Labs, Inc. Nicotine Salt.;
EIR for Biologics inspection of Tjoapack Netherlands BV ending 05/25/2018 at the location in Etten-
2019-10526 FDAZILLA Leur, Netherlands
The Response for Biologics inspection of Wyeth Pharmaceutical Division of Wyeth Holdings LLC ending
2019-10487 FDAZILLA 04/19/2018 at the location in Sanford NC etc
EIR for Human Drugs inspection of AbbVie Inc. ending 07/02/2018 at the location in North Chicago IL
2019-10326 FDAZILLA ETC
WINSTON RED BOX SE0000004, WINSTON WHTE BOX SE0000005, WINSTON WHITE 100'S BOX
2019-10298 ITG BRANDS SE0000006 ETC
2019-10289 Food and Water Watch HUMAN FOOD & ANIMAL FEED INSP & THE NUMBER OF FIELD INVESTIGATORS
FDA FOI request for any information concerning the FDA documents, correspondence, letters,
memorandum (internal and external to FDA), and studies and communications related to vaping
related illnesses. This includes, but is not limited to, all documents from FDAs Forensic Chemistry
2019-10244 BURDOCK GROUP Center related to the incidents of lung illnesses following vaping product use. ;
2019-10157 EXPERIEN GROUP LLC Substantive Summary for the Breakthrough Designation Request Q191517 from CDRH OHT-7.
2019-10142 Genomic Health, Inc. K163628
Date Range: 01/01/2019 - 10/01/2019; All documents pertaining to TC0005069 including a copy of
2019-10096 Rutgers Center for Tobacco Studies the complaints against EonPods LLC referenced in https://www.fda.gov/media/128983/download;
2019-10039 COGENCY GLOBAL INC. NDA 20007 July 7, 2011 Approval Letter, ETC
Any and all documents, from January 1, 2013 to present, related to the U.S. Food and Drug
Administration (FDA)s authorization of 23andMe to market direct-to-consumer, health-related genetic
2019-9770 CENTER FOR FOOD SAFETY tests in the United States.
Date Range: 11/01/2018 - 11/15/2018; Requesting determinative/confirmatory analytical method for
2019-9779 Zoetis Inc. NADA 141-508 (Experior), approved on 11/6/2018;
2019-9743 CENTER FOR CONSUMER FREEDOM 2019-4476; IMPOSSIBLE FOODS - COMMUNICATIONS WITH CFSAN 6/1/19-10/4/19
Epidiolex in (PDF & Excel) for case numbers: 16021303, 15966062, 15728077, 16133101, 16419204,
16413400, 15684401, 16451974, 16324298, 16161255, 16211259 and 16425150. If possible, please
2019-9656 Point Seventy Two email the findings directly to quinn.lin@point72.com.
2019-9636 Korinne Taylor TESTING RESULTS
2019-9319 Global Protection Corp. K141059 FIRST PARTY
Copy of the disclosable portions of the following MAUDE forms, regarding TOF WATCH: 3014288445-
2019-9337 FOI Services, Inc. 2019-00005; 3014288445-2019-00006; and 3014288445-2019-00007.;
2019-9287 WIRED NEWS QUINCY BIOSCIENCE, MADISON, WI - PREVAGEN 483
2019-8780 MILLER ROSNICK D'AMICO AUGUST & BUTLER PC MAXHEALTH CORP - CAREX E-Z BATH AND SHOWER SEAT WITH HANDLES FORM 3500A MEDWATCH
MCDONALD'S SALADS, MEXICAN-STYLE RESTAURANTS, CILANTRO AND BASIL - CYCLOPORIASIS
2019-8765 FAEGRE BAKER DANIELS OUTBREAK 2018
Copies of all information pertaining to the Food and Drug Administrations investigation of the
2019-8757 Schubert Jonckheer & Kolbe LLP presence of Vitamin E acetate in vaping products containing tetrahydrocannabinol (THC).
Copies of all information pertaining to the Food and Drug Administrations investigation of the
2019-8757 Schubert Jonckheer & Kolbe LLP presence of Vitamin E acetate in vaping products containing tetrahydrocannabinol (THC).
2019-8752 PEOPLE FOR THE ETHICAL TREATMENT OF ANIMALS PHS ASSURANCE D16-00650, D16-00662, D16-00655, ETC 1/18 TO 1/31/19
483 for Human Drugs inspection of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
2019-8700 FDAZILLA ending 06/28/2019 at the location in Elkton VA etc
2019-8537 Gutride Safier LLP RECS RE PARKAY BUTTER SPRAY
- A list/summary of all respiratory cases associated with vaping products, as described in the press
release here: http://www.dph.illinois.gov/news/illinois-resident-experiencing-respiratory-illness-after-
2019-7671 CONSUMER REPORTS vaping-dies - ETC
A summary/list of all Safety Reports, filed from Jan. 1, 2016 to the present, through the HHS Safety
Reporting Portal for problems related to dietary supplements. Please include a description of the
2019-7478 CONSUMER REPORTS problem cited (long and short). ;
2019-7352 FAEGRE BAKER DANIELS DEL MONTE FOOD, INC - CYCLOSPORA CAYETANENSIS LINKED TO PRE CUT VEGETABLES
2019-7177 Dr. Reddy's Laboratories Inc. Chemistry and labeling supplements ANDA 203649 C
2019-7103 FOI Services, Inc. 94 Gardasil case reports
2019-6994 HENKEL & COHEN PA CAITO FOODS - SALMONELLA OUBREAK AND RECALL OF FRESH CUT MELONS 2019
2019-6757 ROCKY MOUNTAIN POISON AND DRUG CENTER 4Q18 CASES - AER
Powerpoint slides, student manuals, and instructor manuals if available FDA Classroom Training
Course Numbers: IM101 Import Operations IM116 Import Operations and Import Entry Review FDA
on-line training courses requesting Lectora source files IM8005W Import Alerts/Import Bulletins
2019-6670 International Food Protection Training Institute IM8017W Navigating Common Import Documents
HUNTERDON, MONMOUTH, SUSSEX, AND SOMERSET COUNTIES ROMAINE LETTUCE OUTBREAK
2019-6455 BOSTON GLOBE SPRING 2018
2019-6388 ROCKY MOUNTAIN POISON & DRUG CENTER ACETAMINOPHEN PREPARATIONS - ISRS 10383250, 10667582, 11805298, ETC
2019-6209 GREENBERG TRAURIG K081010
Requesting Annual Report data submitted to the Agency for the reporting periods of 2007-2012 for
2019-6051 Xttrium Laboratories, Inc. ANDA 075911, Lactulose Solution, USP
Records created by or submitted to the Bad Ad program for vaccine biologic products, including
reports, complaints, letters, violations, etc. from the start of the Bad Ad program in May 2010 until
2019-6048 Kelly Emanuel today.
2019-5673 Jamee Cook P060028 RESPONSE TO WARNING LETTER
FLURAZEPAM HCL CAPS ANDA 71-205, THIORIDAZINE HCL TABS ANDA 72-369, FLUVOXAMINE
2019-5571 HERITAGE PHARMACEUTICALS INC MALEATE TABS ANDA 75-894, ETC
2019-5151 Harrington Films Date Range: 01/01/2018 - 12/31/2018; I'm requesting all calendar records for Peter Cassell;
2019-5104 Altria Client Services PHILIP MORRIS USA INC - PLAN FOR REVIEW OF PROVISIONAL SE RPTS 4/5/18
2019-5045 Harrington Films Calendar records for Jennifer Argabright
Copies of all correspondence between Senator Tim Kaine's office and the Federal Drug Administration
2019-5024 MOTHER JONES concerning e-cigarettes, the company JUUL, Pax Labs, or tobacco regulation etc
2019-4322 GENICON DEN150028
2019-4234 HILL-ROM MedWatch report 5086257
483 for Medical Devices & Rad Health inspection of Martech Medical Products, Mexico ending
2019-4181 FDAZILLA 09/21/2006 at the location in Mexicali, Mexico etc
483 for Medical Devices & Rad Health inspection of Martech Medical Products, Mexico ending
2019-4181 FDAZILLA 09/21/2006 at the location in Mexicali, Mexico etc
2019-4133 KGW 7-ELEVEN INC, CENTER FOR TOBACCO PRODUCTS - CORR REGARDING ILLEGAL SALES TO MINORS
Breakdown of the number of positions/incumbents of field investigators assigned to the divisions of
2019-4083 Food & Water Watch the Office of Human and Animal Food Operations
2019-3882 Williams, Lisa M PMA P050027
2019-3469 Global QMS, Inc. I would like an Excel file of Product Code to Patient Problem Codes from within the MAUDE database
2019-3391 LEWIS BRISBOIS ET AL RANCHO MESA CARE CTR - HOYER LIFT 8/1/16 TO 12/31/18 AER
2019-3034 ALLEN MEDICAL SYSTEMS Medical Device Report 8349403
Reports who have gone into the 21 CFR 803.19 instead of the MAUDE database from OLYMPUS
2019-2945 Tower House Partners LLP MEDICAL SYSTEMS CORP. between 2013 and the end of 2018
FDA's review memoranda for the following FCNs, all filed by BASF and all pertaining to octadecyl 3,5-
di-tert-butyl-4-hydroxyhydrocinnamate: FCN 181, FCN 386, FCN 1206 (replaced by FCN 1557), FCN
2019-2816 FOI Services, Inc. 1557, and FCN 1605
2019-2599 FOI Services, Inc. CTP documents regarding the PHI criteria for pending provisional SE applications.
2019-2610 Department of Medicine, Tal-Aviv University VAERS RECS
Documents related to FDA's conditional designation of SYMDEKO (IVACAFTOR; IVACAFTOR,
2019-1840 Greenleaf Health TEZACAFTOR) as a rare pediatric disease product application
O'Neill Institute for Nat'l & Global Health Law, Georgetown Univ. Law Consumer perception study or studies relating to "little cigars" or "filtered cigars" referenced in letter
2019-1618 School to Ann Simoneau ETC
2019-1395 Zoetis Inc. NADA 140-338
2019-1324 Ethicon, Inc. K023594
Unimark Remedies Ltd. ANDA and DMF eCTD filings 1. ANDA 207887 2. ANDA 207704 3. ANDA
2019-1233 Unimark Remedies Limited Ahmedabad 202859 etc.
2019-752 Paul Gottinger SHUTDOWN TALKING POINTS 12/22/2018 - 01/20/2019
2019-772 ConvaTec Inc. K180205, K181206, K173675, ETC
2019-375 The Weinberg Group Opternative, Inc. original response to the October 30, 2017 Warning Letter
PM0000010, PM0000011, PM0000012, PM0000013, PM0000014, PM0000015, PM0000016, and
2019-384 FOI Services, Inc. PM0000017
2018-9804 E.M.M.A. International Consulting Group DEN160026
2018-8603 Capillary Biomedical, Inc. K162812
2018-8459 Invacare Corporation K151199
2018-7681 FOI Services, Inc. K152029
2018-7526 Cortical Metrics, LLC K141865 K122149 K133382 ;
2018-7544 Jamee Cook PMA approval letter in regards to Mentor MemoryGel P030053
2018-7218 PROPERTY OF THE PEOPLE POULTRY HATCHERIES - EIRS, 483S
RPT FOR EACH CLNCL TRIAL RELIED UPON BY THE FDA WHEN APPROVING FLUARIX FOR SIX MONTH
2018-7214 SIRI & GLIMSTAD LLP OLD BABIES
2018-6957 Neuberger and Associates LLC K172740, K172740/S001 ETC
2018-6740 SWEDISH MATCH USA INC SUBSTANTIAL EQUIVALENCE RPTS FOR SE0014026 AND SE14063
2018-6427 Dr Natalia Novikova RECS RE STUDIES, ADVERSE EVENT REPORTS VAGINAL REJUVINATION ETC 01/01/2010 - 08/04/2018
2018-6380 Piper Access K061771
2018-5874 PFIZER INC BLA 125031 / S-180
2018-5768 TRACOE medical GmbH K083641
2018-5756 Hogan Lovells K163510
2018-5411 Quidel Cardiovascular Inc. K172787
2018-5186 Matrix Medical Devices, LLC K172258
2018-5061 Acoustiic Inc. DE NOVO DEN150011; SONACARE
LIVA NOVA, DEUTSCHLAND - MYCOBACTERIA INFECTIONS AT WELLSPUN YORK HOSPITAL, YORK, PA
2018-5051 KLINE & SPECTER 2014 TO PRESENT
2018-4894 Next Orthosurgical, Inc. K160895 K133386 K120578 ETC
2018-4808 Terumo Heart Inc. K172258
SPEECH BY LARRY G KESSLER 10/04/2000 FDA and the Reuse of Single Use Devices: Policy Now
2018-4647 FOI Services, Inc. Established"
2018-4588 FOI Services, Inc. NDA 202158
2018-4454 Medtronic K173489
2018-4172 BOSTON SCIENTIFIC CORPORATION K172258
YEARLY MEDICAL DEVICES ESTABLISHMENT REGISTRATION AND DEVICE LISTING DATA 01/01/1999 -
2018-4064 THE OHIO STATE UNIVERSITY 05/01/2018
2018-3941 THE UNIVERSITY OF CHICAGO Review of BLA 12554/S-048, S-049, S-050, S-051, S-052, S-061, S-062, S-064, S-065, S-066
2018-3684 FOI Services, Inc. BLA 125554
2018-3650 Troutman Sanders, LLP RECS RE PHI ASSESSMENTS, GUIDELINES FOR TOBACCO PRODUCTS, ETC
2018-3482 LATHAM & WATKINS LLP INITIAL PUBLIC HEALTH IMPACT ASSESSMENT CONDUCTED 2013
RECS RE FDA DECISIONMAKING REGARDING THE TERM NATURAL FOR THE PURPOSES OF FOOD
2018-3295 CENTER FOR FOOD SAFETY LABELING
2018-2696 Eli Lilly and Company NDA 203314/S-008
2018-2464 Quentin de Snoeck K170195
2018-2118 Lumendi, LLC K171158
2018-2065 Key Surgical, Inc. K152948
2018-1990 Allan N. Karlin & Assocaites ST JUDE MEDICAL WARNING LETTER RECS 01/01/2016 - 03/05/2018
2018-1566 LEXAMED K162701
2018-1580 Walkup, Melodia, Kelly and Schoenberger KLS MARTIN LP - ZURICH DISTRACTION SYS K010139
2018-1318 Bard Peripheral Vascular, Inc. K113658, K071699, K150402, ETC
2018-1225 Steve Lufkin K082538 K111976 K162740
2018-1171 PENTAX MEDICAL CO K760171, K770879, K772055, ETC
PFIZER, QUILLIVANT XR COMMUNICATIONS RE CURRENT MANUFACTURING DELAY 10/01/2017 -
2018-1091 April Mensik 02/05/2018
2018-475 COGENCY GLOBAL, INC DEN160003 BP060002 BP150262 etc
2017-10612 The Epstein Law Firm, P.A. IMS TRADING CORP, IMS PET INDUSTRIES, CHINA - CORR, TESTING, ETC 01/01/2008 - 12/31/2014
2017-10466 DEKA R&D K162812
2017-9847 Organogenesis Inc. K152033 K153754
2017-9604 Ark Surgical Ltd. DEN150028
2017-9633 KEYSTONE INDUSTRIES K143033
2017-9124 JOHNSON & ROCHE ATTYS AT LAW STRYKER STANDARD VIEDO CART WITH MONITOR INSP RECS, APRVL RECS
2017-9072 Snidar, Richard R INDIVIDUAL RECS
2017-8940 NIMIO AB K131686 K143213
2017-7283 Prime Herbs Corporation PRIME HERBS CORP - REGISTRATION
2017-7190 WHPM INC 510K K163225 AFIAS iFOB
2017-6464 Westwood Advisors Incorporated RECS RE HIRONIC CO LTD SIGNIFICANTLY REGULATED ORGANIZATION
2017-6174 WHPM INC EIKEN CHEMICAL CO LTD - K092330
2017-5548 APN HEALTH LLC K160210
2017-5442 Wilson Sonsini Goodrich & Rosati BETACONNECT, MYBETA APP BLA 103471/S186,S189 - SBA
2017-4872 ROPES & GRAY LLP GEN1700146
2017-4372 Bard Peripheral Vascular, Inc. K162467; K072618; K120242; ETC
2017-4184 FU, YU 23ANDME - DE NOVO PATHWAY FOR THE PERSONAL GENOME SERVICE (PGS) DEN160026
2017-2568 COOPERSURGICAL INC K162051 DEN150028
2016-10389 ConMed Corporation K13393
2016-10151 Zebra Medical Vision Ltd K113725 K140342 K120161
MRS SYSTEMS, INC ASPEN BREAST AND ASPEN LUNG - AFTERMARKET PRODUCT INVESTIGATION
2016-9237 MRS Systems, Inc. COR16000111
2016-8132 DEKA R&D K103477
ABBOTT LABORATORIES FREESTYLE DIABETIC TEST STRIPS - RECS RE IMPORTATION OF DIABETIC TEST
STRIPS TO THE US AND/OR SALE OF INTERNATIONAL VERSION OF TEST STRIPS IN THE US 01/01/2011 -
2016-6963 Kerr, Russell and Weber, PLC 08/18/2016
APPLE - HEALTHKIT, RESEARCH KIT, CAREKIT, ETC APPLICATIONS; MOBILE MEDICAL APPLICATIONS
2016-5690 MERCHANT, BRIAN GUIDELINES 2/9/15, ETC
USE OF SECTION 1201 OF THE DIGITAL MILLENNIUM COPYRIGHT ACT IN FDA ENFORCEMENT
2016-4177 ELECTRONIC FRONTIER FOUNDATION ACTIVITIES
DRUG SAFETY COMMUNICATION: FDA REVIEW FINDS LONG-TERM TREATMENT WITH BLOOD-
2015-9508 Thomas Marciniak THINNING MEDICINE PLAVIX - META-ANALYSIS, MANAGEMENT PLAN 11/01/2014 - 11/06/2015
2015-7383 DENTONS US LLP K112484, K112533, K112664, ETC
EMORY UNIV, GILEAD SCIENCES INC - EMTRIVA (EMTRICITABINE) CLNCL TRIALS, EXPERIMENTAL
2015-3368 ABRUE-VELEZ, ANA MARIA STUDIES, APRVL, ETC
Status
Closed (Fee-related)
Not Reasonably Described
Closed
Acknowledgement Letter
Closed
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No Record(s)
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Delogged (not a FOIA Request)
Closed
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Duplicate Request
Closed
Partial Response
Closed
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Withdrawn Closed w/o Charges
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No Record(s)
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Closed for Other Reason
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Closed Denial
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No Record(s)
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No Record(s)
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Closed Denial
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Not An Agency Record
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Referral (Outside FDA)
Closed
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Closed Denial
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Closed Denial
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No Record(s)
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Closed Denial
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No Record(s)
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Closed
Closed

Partial Response
Closed
Partial Response
Closed
Closed
Closed
Closed
Closed

Closed
Closed
Closed
No Record(s)
Closed
Closed
Closed
Closed
Closed
Closed
Partial Response
Closed
Closed Denial
Closed
Partial Response
Closed
Closed
Closed
Closed
Pending Action
Closed Denial
Closed
Partial Response
Closed
Closed
Closed
Closed
Duplicate Request
Closed
Closed
Closed
Closed
Pending Action
Pending Action
Closed
Closed
Closed
Partial Response
Closed
Closed
Partial Response
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Partial Response
Partial Response
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed Denial
Closed
Closed
Closed
Closed
Pending Action
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Withdrawn w/Charges
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Closed
Partial Response
Closed
Closed
Closed
Pending Action
Closed
Closed
Partial Response
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
Closed
Closed
Partial Response
Partial Response
Closed
Closed
No Record(s)

FDA FOIA Closed Log - January 2020 - 0

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Copyright:

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FDA FOIA Closed Log - January 2020 - 0

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Copyright:

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Center for Pharmaceutical Information and Engineering Research of

Center for Pharmaceutical Information and Engineering Research of

Center for Pharmaceutical Information and Engineering Research of

Review Package or Approval Package of Caplyta, approved on 12/20/2019. Moreover, a

MEDISCA IN, PROFESSIONAL COMPOUNDING CENTERS OF AMERICA - COMMUNICATIONS PUBLISHING

WHARTON SCHOOL OF THE UNIVERSITY OF PENNSYLVANIA,

Response to warning letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-

2018-5116, 2018-5908, 2018-6156, 2018-6156, 2018-7288, 2018-8118, 2018-8255, 2018-8472, 2018-

INSTITUTE OF PHARMACOLOGICAL SCIENCES OF SOUTHERN

Not Reasonably Described

Withdrawn Closed w/o Charges

Withdrawn Closed w/o Charges

Withdrawn Closed w/o Charges

Withdrawn Closed w/o Charges

Withdrawn Closed w/o Charges

Not An Agency Record

Withdrawn Closed w/o Charges

Not Reasonably Described

Withdrawn Closed w/o Charges

Withdrawn Closed w/o Charges

Delogged (not a FOIA Request)

Not Reasonably Described

Withdrawn Closed w/o Charges

Withdrawn Closed w/o Charges

Withdrawn Closed w/o Charges

Withdrawn Closed w/o Charges

Withdrawn Closed w/o Charges

Withdrawn Closed w/o Charges

Withdrawn Closed w/o Charges

Withdrawn Closed w/o Charges

Withdrawn Closed w/o Charges

Referral (Outside FDA)

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