Setter: A FOIA Getter

Hi, I would like to request more details on a recent case of death reported on FAERS database for Crenessity (Case ID: 26554981). It is a drug that are garnering a lot of interest among CAH caregivers, and I believe it is an important information to provide in deciding whether to initiate the therapy for their childre…

Requester: Joe Kim - RBC Capital Markets

With respect to EPKINLY/epcortimab , please provide the review documents, that could be labeled as “statistical reviewer”, “multidisciplinary review”, “approval letter”, “summary basis for regulatory action”, “summary review”, “clinical review memo”, “statistical review memo”, “clinical pharmacology review”, and or an…

Requester: Kristen Sellers - FOIA Professional Services

To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Baylab USA, LLC Texas United States End Dates of inspection: 31 Jan 2024 FEI: 3017517827 Project Area: Devices Classification: OAI I confirm that Clarivate Analytics will be charg…

Requester: Molly Bowman - Clarivate Analytics

Records related to an FDA internal pharmacovigilance review document concerning gastrointestinal safety risks associated with diabetes and weight loss medications, November 2022.

Requester: Desmond Butler - White Mountain Films

To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: B. Braun US Pharmaceutical Manufacturing, LLC California United States End Dates of inspection: 21 Nov 2025 FEI: 2021236 Project Area: Drugs Classification: OAI I confirm that Cla…

Requester: Molly Bowman - Clarivate Analytics Espana (SAU)

Please share the Form 483 for Genzyme Ireland Limited. Inspection details: • End Date: Jan 20, 2026 • Site: Genzyme Ireland Limited, Waterford, Ireland • FEI Number: 3003809840

Requester: Sonika Shinghal - Sovish

To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: TriRx Medical, LLC Florida United States End Dates of inspection: 06 Mar 2026 FEI: 3027390974 Project Area: Devices Classification: VAI I confirm that Clarivate Analytics will be …

Requester: Molly Bowman - Clarivate Analytics Espana (SAU)

To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: BioTissue Holdings Inc Florida United States End Dates of inspection: 18 Feb 2026 FEI: 3009809074 Project Area: Devices Classification: VAI I confirm that Clarivate Analytics will…

Requester: Molly Bowman - Clarivate Analytics Espana (SAU)

To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: NeuroCareAI, Inc. dba SaveLife AI, Inc. Texas United States End Dates of inspection: 12 Dec 2025 FEI: 3034656245 Project Area: Devices Classification: VAI I confirm that Clarivate…

Requester: Molly Bowman - Clarivate Analytics Espana (SAU)

To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Compass Health Brands Corp. Ohio United States End Dates of inspection: 27 Feb 2026 FEI: 3005182235 Project Area: Devices Classification: VAI I confirm that Clarivate Analytics wi…

Requester: Molly Bowman - Clarivate Analytics Espana (SAU)

To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: The Side Lyer Company LLC. Florida United States End Dates of inspection: 12 Mar 2026 FEI: 3030492371 Project Area: Devices Classification: VAI I confirm that Clarivate Analytics …

Requester: Molly Bowman - Clarivate Analytics Espana (SAU)

To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Smithfield Bioscience Inc ohio United States End Dates of inspection: 23 Dec 2025 FEI: 1527761 Project Area: Drug Quality Assurance Classification: OAI I confirm that Clarivate An…

Requester: Molly Bowman - Clarivate Analytics Espana (SAU)

To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Unik Orthopedics, Inc California United States End Dates of inspection: 13 Mar 2026 FEI: 3019006180 Project Area: Devices Classification: VAI I confirm that Clarivate Analytics wi…

Requester: Molly Bowman - Clarivate Analytics Espana (SAU)

Please share the Form 483 for Celgene Corporation. Inspection details: • End Date: Jul 18, 2025 • Site: Celgene Corporation, Summit, United States • FEI Number: 3004991673

Requester: Sonika SHinghal - Sovish

Please share the Form 483 for Grifols Therapeutics LLC. Inspection details: • End Date: Feb 05, 2026 • Site: Grifols Therapeutics LLC, Clayton, United States • FEI Number: 1050373

Requester: Sonika Shinghal - Sovish

Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Food and Cosmetics inspection of Health Pharma USA LLC, located at 1600 Hart Street, Rahway, New Jersey (NJ) 07065, United States, inspection ending 11/18/2025 (FEI 3013856804). The 483 (in electr…

Requester: Jhan Ray Barril - Redica Systems

Pursuant to the Freedom of Information Act (FOIA), I respectfully request copies of the Form FDA 483 (Inspectional Observations) issued for the inspections listed below. For each establishment, I request only the Form FDA 483, including any cover pages or attachments that are part of the Form 483 package. I am NOT req…

Requester: Byungsun Park

I am the QA director for Penguin Natural Foods, we had an inspection in February 2025, and the inspection report was issued via PDF, but the password given did not work. I emailed to request an update but have not heard back. was wondering if i could get the report re-issued? The Password for your EIR file is 8Dm,y1ej…

Requester: Kathy Do - Penguin Natural Foods

FF 2005-16634

Requester: Peter Smith - Undark Magazine

All communications, emails, meeting summaries, notes, calendars, briefing materials, decision memos, or other records between any FDA officials/staff and representatives of Arnold Ventures (including Arnold Ventures Foundation, Laura and John Arnold Foundation, or any affiliated entities) concerning uniQure's AMT-130 …

Requester: WILLIAM m. POWELL

Dear, Idorsia Pharmaceuticals kindly requests the following reports/memoranda from the Agency: DeConti, S. Elimination (or Modification) of the REMS for products in the ERA pharmacologic class for EFT risk. February 28, 2025. DARRTS Reference ID: 5540726 Tran, T. Teratogenic Risk of Bosentan, Ambrisentan, Macitentan, …

Requester: Rafael K. Varaschin, PhD. - Idorsia Pharmaceuticals Ltd.

Hello, I am an investment professional and this is a request under the Freedom of Information Act. We would like to request the FDA meeting minutes between January 1st-29th, 2026 regarding Catalent located at 1300 S Patterson Drive, Bloomington, IN 47403 and a meeting held on January 14th, 2026 in response to Form 483…

Requester: Marissa Conte - Point72

Requesting FDA FAERS/AEMS case number 25521503 with suspected product Enjaymo.

Requester: Jonathan Helander

I request copies of the following FDA inspection records: • FDA Form 483 • Establishment Inspection Report (EIR) • Any inspection classification or close-out correspondence Facility: Smithfield BioScience, Inc. Cincinnati, Ohio, USA FEI: 1527761 Inspection end date: 23 December 2025 Inspection type: Drugs / Biologics …

Requester: Dolf Gijtenbeek - Friday Life Sceinces B.V.

All inspection records (including 483s) for Biovire's manufacturing facility in Brighton, Michigan. I believe this facility makes human drugs.

Requester: Sung Chun Kim - Sung Chun Kim, Esq.

We would like to request documentation relating to NDA 019762, in accordance with the attached request letter.

Requester: Lesley White - Solve Consulting International

All communications, emails, meeting summaries, notes, calendars, briefing materials, decision memos, or other records between any FDA officials/staff and representatives of Arnold Ventures (including Arnold Ventures Foundation, Laura and John Arnold Foundation, or any affiliated entities) concerning uniQure's AMT-130 …

Requester: Kevin Kiely

All communications, emails, meeting summaries, notes, calendars, briefing materials, decision memos, or other records between any FDA officials/staff and representatives of Arnold Ventures (including Arnold Ventures Foundation, Laura and John Arnold Foundation, or any affiliated entities) concerning uniQure's AMT-130 …

Requester: Tyler J. Meservy

I request copies of the complete administrative case files for the following closed FOIA requests submitted to the U.S. Food and Drug Administration: -FOIA Request No. 2020-2620 (submitted by Animal Legal Defense Fund) -FOIA Request No. 2021-4115 (submitted by Animal Legal Defense Fund)

Requester: Juan Vassallo - Investigate Midwest

Kyndrisa (drisapersen) (pharma company/sponsor: BioMarin Pharmaceutical) Complete Response Letter (CRL)

Requester: kaylin bower

In February 2026, Cingulate was issued a Form 483 for their NDA of the drug CTX-1301. What exact date was the Form 483 issued? I don't need to know the question(s) on the Form 483. I just want to know the date it was issued.

Requester: Ron Pugh

Pursuant to the Freedom of Information Act, 5 U.S.C. § 552, and FDA's implementing regulations, I request the complete FAERS case files — including all initial and follow-up ICSR submissions — for the adverse-event reports identified in the table below. Case numbers are drawn from the FAERS Public Dashboard. Manufactu…

Requester: Desmond Butler - White Mountain Films

The final approval routing summary, any other approval routing summaries, and all final and/or tentative approval letters for Abbreviated New Drug Application (ANDA) 208959

Requester: Thomas Maas - Odom & Des Roches

Medical device: Cochlear Implant - C1422 (SRA) Cochlear Nucleus Model (Cochlear America); Original Serial number: 1020141653991, Straight electrode C1422; Date of 1st adverse event: Nov. 25,2013, University Medical Center, AZ; Date of 2nd adverse event: July 16-21, 2015, John Hopkins, MD. Adverse Event: Defective elec…

Requester: Katherine Summerfeldt

Requesting Form 483 for Inspection ID: 1290398 (End Date: 10/17/2025) Product Type: Drugs For the following: Alps Pharmaceutical Industrial Co., Ltd. 2-10-50 Furukawachomukai-Machi Hida, Gifu 509-4241 Japan FEI Number: 1073

Requester: Matthew Shelton - Sheffield Pharmaceuticals

As a Qualified Person Responsible for Pharmacovigilance for KalVista Pharmaceuticals Limited, I kindly request, for the purpose of monitoring drug safety, a redacted narrative of the individual case safety report (ICSR) from the FDA Adverse Event Reporting System (FAERS) Public Database with the following details: Cas…

Requester: Jutta Syha - Arriello s.r.o.

Unredacted (first party) format request FOI Request- FDA ANDA Review Assessment report for ANDA 219319 of Gabapentin Capsules USP, 100 mg, 300 mg and 400 mg in Unredacted (first party) format Signed Authorization letter is attached herewith for your reference

Requester: Lavish Patel - STALLION LABORATORIES PRIVATE

Please release the pdf copy of the Form 483 issued to SMS Pharmaceutical Limited - Unit VII (FEI: 3008654585) for the inspection that ended on Dec 12, 2025. Thanks.

Requester: Dr. Bhawna Ag

483 issued to Yuki Gosei Kogyo Co., Ltd. Iwaki, Japan (FEI: 3002808534) on FDA Drug Inspection (260206)

Requester: Mari Yonomoto - Office YM

To Whom It May Concern: Pursuant to the Freedom of Information Act (FOIA), as amended, 5 U.S.C. §§ 552, et seq., COGENCY GLOBAL INC. hereby requests all documents from the U.S. Food and Drug Administration’s summary review of the supplemental New Drug Application for iDose TR (travoprost intraocular implant) (NDA 2180…

Requester: Joanna McCall - COGENCY GLOBAL INC.

NDA 205437 OTEZLA provide the carton label and the inner/outer blister pack labels for the below NDC’s. Configurations for 30 mg BID Dosage 55513-369-55 : Package configuration: 28-day treatment initiation pack Tablet strength: 55-tablet blister pack including tablets for titration and maintenance dosage: 4 tablets (1…

Requester: Shipra Patel - Sandoz Inc.

A copy of the EIR for the inspection of the California Stem Cell Treatment Center, Country Club Drive, Rancho Mirage, California -- conducted from July 17, 2017 to July 26, 2017.

Requester: Debbie Cenziper - ProPublica

A copy of the EIR for the inspection of the California Stem Cell Treatment Center, Spalding Drive, Beverly Hills, Ca., conducted from July 21, 2017 to July 27, 2017.

Requester: Debbie Cenziper - ProPublica

On behalf of the White Coat Waste Project (WCW) and pursuant to the Freedom of Information Act (FOIA), 5 U.S.C. § 552, I request records from January 1, 2025 through December 31, 2025 relating to the adoption, retirement, or other live disposition of animals used by FDA intramural laboratories for research or testing …

Requester: Kailey Mauro - White Coat Waste

To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Mark Dacey, M.D Lynden, WA United States End Dates of inspection: 08 Nov 2024 FEI: 3031610524 Project Area: Bioresearch Monitoring: Drugs Classification: OAI I confirm that Clariv…

Requester: Molly Bowman - Clarivate Analytics Espana (SAU)

To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: AQ USA Inc., d.b.a Ross Healthcare Inc Lynden, WA United States End Dates of inspection: 12 Aug 2025 FEI: 3015167023 Project Area: Drugs Classification: OAI I confirm that Clariva…

Requester: Molly Bowman - Clarivate Analytics Espana (SAU)

To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Bertrand P. Cole, D.O./Activmed Practices and Research, LLC Portsmouth United States End Dates of inspection: 16 May 2025 FEI: 3036830130 Project Area: Drugs Classification: OAI I…

Requester: Molly Bowman - Clarivate Analytics Espana (SAU)

FF Request FDA-FOIA-2026-407

Requester: Orca1 Orca - Orca1 Digital Intelligence, LL

Records related to the special protocol assessment agreed between the FDA and Candel Therapeutics for the study of CAN-2409 in localized intermediate-to-high-risk prostate cancer (NCT01436968)

Requester: Imogen Mansfield - Cantor Fitzgerald

We are requesting a copy of the EIR for the inspection of the BM Rockford IL location (FEI# 3000206206). The management that was in place at that time is no longer with the company so we do not have a copy of this document and need to obtain one for our files.

Requester: Cheryl Webb - Biomat USA