Setter: A FOIA Getter
22623 requests collected across all agencies
FF Request: 2024-2776; 2024-2777; 2024-2778; 2024-2779
Requester: Christopher Womack - FOIA Document Source
Form 483 issued to Patheon Italia S.p.A (FEI: 3004110157). Site address: Via Morolense 5, Ferentino, Frosinone 03013, Italy. Inspection Date: January 22, 2026 - January 30, 2026. CELLTRION would like to confirm the details specifically for the product area of 'drugs'.
Requester: CELLTRION CELLTRIO - Celltrion, INC.
I am requesting FDA Warning letters for violations of cGMP issued by CDER from January 2009 to January 2021.
Requester: Bradley Katcher - Harvard University PhD Student
As the Official Correspondent for CooperSurgical, Inc, I would like to request in First Party Format (unredacted) a copy of the EIR for the inspection performed by Investigator Matthew D Schnittker from 1/29-2024 - 2/1/2024 at the facility located at 825 Wurlitzer Dr., North Tonawanda, NY 14120-3041 (FEI 131626).
Requester: Brian Szeremeta - CooperSurgical, Inc.
I would like to see the most recent 483 forms for the following Grifols locations in Louisville: Talecris Plasma Resources at 5037 Preston Highway Grifols Freedom Plasma Donation Center at 8209 Preston Highway
Requester: Lillian Metzmeier - The Courier Journal
Pursuant to the Freedom of Information Act, 5 U.S.C. § 552, I request all OSE, DPV-I, and DEPI-I records associated with Newly Identified Safety Signal 1004823 (GLP-1 receptor agonist / intestinal obstruction / ileus), from signal opening through closure, excluding internal emails and inter-office correspondence. Spec…
Requester: White Mountain Films - White Mountain Films
Pursuant to the Freedom of Information Act, 5 U.S.C. § 552, I request copies of the following two specifically identified FDA documents relating to the GLP-1 receptor agonist intestinal obstruction/ileus safety signal (Newly Identified Safety Signal 1004823): 1. DPV-I/DEPI-I Pharmacovigilance Review dated November 1, …
Requester: White Mountain Films - White Mountain Films
Please provide Tentative Approval Letter of Lumateperone Capsules 10.5mg;14mg;21mg;28mg;42mg for the following mentioned Applicants: 1. DR. REDDY'S LABORATORIES LIMITED : ANDA 219229 2.ALKEM LABS LTD : ANDA 219200 3. AUROBINDO PHARMA LIMITED : ANDA 219085 4. HETERO LABS LIMITED : ANDA 219142 5. MSN LABORATORIES PRIVAT…
Requester: Srinivas Gurram - Zydus Pharmaceuticals USA INC
I am requesting to receive the summary case reports for the following case IDs from the AEMS system: 26523152, 26523150, 26513193, 26370168
Requester: Dana Powell
FF Request: 2026-2579
Requester: Jay Howard - E&J Gallo Winery
A copy of the Establishment Inspection Report for the inspection of Exela Pharma Sciences of Lenoir NC that was conducted by FDA from November 4, 2024 to November 15, 2024.
Requester: Jamerra Cherry - Hyman Phelps & McNamara, P.C.
Complete reports and all associated documentation for the following case numbers: Case 24667432, Case 26472804, Case 26147180, Case 26203211.
Requester: Gladys Gonzalez - Insmed Incorporated
Inspection Report for FDA audit conducted on 3/5/26 at our facility. We did not receive a report or any documentation.
Requester: Jean Jones, QA Manager for the Company - The Vermont Maple Sugar Compan
FF Request: FOIA 2024-3035; FOIA 2024-3186; FOIA 2024-3190; FOIA 2024-3191; FOIA 2024-3192; FOIA 2024-3915; FOIA 2024-3196; FOIA 2024-3197; FOIA 2024-3198; FOIA 2024-3199; FOIA 2024-3202; FOIA 2024-3205; FOIA 2024-3207
Requester: JoNel Aleccia - The Associated Press
Please provide the EIRs for the following two FDA inspections of American Cell Technology LLC, 13794 NW 4TH ST STE 212, SUNRISE, FL, 33325-6217, UNITED STATES 1. Inspection on April 19, 2011 2. Inspection on December 5, 2014
Requester: Debbie Cenziper - ProPublica
FF Request: 2025-1768, 2025-7297, 2025-638, 2025-2674, 2025-3585, 2025-4639, 2025-4027
Requester: White Mountain Films - White Mountain Films
FF Request: 2025-4532, 2025-8903, 2025-1882, 2025-1195, 2024-6833, 2025-11100
Requester: White Mountain Films - White Mountain Films
Requesting latest, current, most up to date approved Labelling (Package insert, Vial and carton), for Sodium Bicarbonate Injection, NDA 019443, held by Abbott .
Requester: Smita Dasmajumdar - Fresenius Kabi USA LLC
I am requesting the FDA application review documents for VYKAT XR approval, including clinical and pharmacology documents.
Requester: Jon Helander - Diadema Partners
I am requesting a copy of the FDA bioequivalence review for ANDA 210323 (Exemestane tablets)
Requester: Jane Li - Praxgen Pharmaceuticals LLC
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Specialty Process Labs LLC Arizona United States End Dates of inspection: 29 Sep 2025 FEI: 3017888878 Project Area: Drug Quality Assurance Classification: OAI I confirm that Clari…
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: ASP Global, LLC. dba Anatomy Supply Partners, LLC. Georgia United States End Dates of inspection: 01 Aug 2025 FEI: 3004824601 Project Area: Compliance: Devices Classification: OAI…
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: Turnco Tool & Instrument, Inc. Texas United States End Dates of inspection: 11 Feb 2026 FEI: 3009241418 Project Area: Compliance: Devices Classification: VAI 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: AR Fabricating Texas United States End Dates of inspection: 11 Feb 2026 FEI: 3010143171 Project Area: Compliance: 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: Gobiquity, Inc Tennessee United States End Dates of inspection: 12 Feb 2026 FEI: 3010539401 Project Area: Compliance: Devices Classification: VAI I confirm that Clarivate Analytic…
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: Diasol, Inc Arizona United States End Dates of inspection: 19 Aug 2025 FEI: 3007137482 Project Area: Devices Classification: OAI I confirm that Clarivate Analytics will be charged…
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: Carlos Timaran, MD Texas United States End Dates of inspection: 15 Jan 2026 FEI: 3040978010 Project Area: Bioresearch Monitoring: Devices Classification: VAI 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: Fresenius Kabi USA, LLC Massachusetts United States End Dates of inspection: 08 Aug 2025 FEI: 3014732157 Project Area: Devices Classification: OAI I confirm that Clarivate Analyti…
Requester: Molly Bowman - Clarivate Analytics Espana (SAU)
We are requesting a copy of the EIR from the FDA inspection from April 2019 of the BM Amarillo TX donor center (FEI 3007118687). We do not have a copy of this document and need it for our files.
Requester: Cheryl M. Webb - Biomat USA
Please release the Form 483 of WuXi AppTec Co., Ltd's March 28, 2025 Inspection at their Plainsboro site. FEI 3033604613
Requester: Dr. Bhawna
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: UCSF Radiopharmaceutical Facility California United States End Dates of inspection: 24 Jul 2025 FEI: 3005947301 Project Area: Drugs Classification: OAI I confirm that Clarivate An…
Requester: Molly Bowman - Clarivate Analytics Espana (SAU)
Inspections and Citations
Requester: Sonika Shinghal - Sovish
I am requesting a copy of the FDA bioequivalence review for ANDA 202602 (Exemestane tablet)
Requester: zhongshui yu
Seeking personal records of VAERS report for Stamaril yellow fever vaccine administered at the travel clinic for San Francisco Public Health Dept at 101 Grove Street, Room 102, SF 94102, tel. 415-554-2860. According to an email from Nurse Manager Pamela Axelson at that office, a VAERS report was filed with Sanofi on J…
Requester: Lisa Klug - www.lisaklug.com
I am requesting a copy of the report for the inspection that occurred at STERIS Corporation, 3010 Williams St., Suite116, Chattanooga, TN 37410 on December 16, 2024, which was conducted by FDA investigator Jamie Webb.
Requester: Becky Aldhizer - STERIS Corporation
We seek copies of the following sections from Abbreviated New Drug Application (“ANDA”) No. 219384, which was filed by Somerset Therapeutics, LLC:
Requester: Ballard Spahr LLP - Ballard Spahr LLP
I am requesting copies of the complete 483 inspection reports for the facility listed below: ¿ Firm Name: Fresenius Kabi Location: 5200 Corporate Parkway, Wilson, NC 27893 FEI: 3008887707 Inspection End Date: 2/13/26 Industry: Human Drugs Please provide the documents electronically by email if possible.
Requester: Kristen Sellers - FOIA Professional Services
See attached FOIA request letter.
Requester: Ballard Spahr LLP - Ballard Spahr LLP
A copy of the February 29, 2025 Complete Response Letter issued by FDA with respect to Zepbound KwikPen (tirzepatide) (NDA 217806) for SUPPL-2 (and referenced in FDA's January 29, 2025 Complete Response Letter for the same supplement).
Requester: Irene Namata - Hyman, Phelps & McNamara
Form 483 for Patheon Manufacturing Services LLC located at 5900 Martin Luther King Jr. Highway, Greenville, North Carolina (NC) 27834, United States (USA) (FEI#: 1018495) for FDA Inspection that completed on or about May 24th, 2024.
Requester: Gregor Stasik - XGen Pharmaceuticals DJB
Please consider this request for a copy of the 03/18/2025 Tentative Approval letter for ANDA No. 219075 for Dronedarone (generic drug). Please consider this request for a copy of the 12/31/2015 Tentative Approval letter for ANDA No. 205682 for Dronedarone hydrochloride (generic drug). Please consider this request for …
Requester: Gorakhnath Tambe - IPD Analytics
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Requester: Chris Nelson - Judicial Watch, Inc.
Name Reproductive Medicine Institute Location 4709 Golf Rd Ste 1000 Skokie, IL 60076-1260 United States FEI 3003966270 Inspection end date 3/9/2026 Type Biologics Document Request 483 and EIR (if available)
Requester: Vivian Nguyen
Criminal records
Requester: Destiny J. Figgers
I'm needing an incident report from queen's medical center nuclear medicine department regarding an incident or injury from a medical device pinching incident that cause injury due to technologist error or mishap?
Requester: Jerry Riggins - Jerry Riggins
Can you please release the Form 483 issued to Novartis Pharmaceuticals Corporation (FEI is 3010353512) in Feb 2026 at Morris Plains, United States.
Requester: Dr. Bhawna
Freedom of Information Act Request for Chemistry and Toxicology Review Memoranda from Food Contact Notifications 2258 and 1901
Requester: Princy Jins - Huntsman
I would like a copy of the summation of the inspection of the Transfusion Medicine Laboratory/ Blood Bank at Greater Baltimore Medical Center (6701 N. Charles Street, Towson MD 21204) that was performed on 2/3/2026 by LT Victoria Bot, MPH, US PHS.
Requester: Kyle Forsythe - Greater Baltimore Medical Center
The Memorandum signed February 19, 2026, by the Principal Deputy Commissioner, Sara Brenner, that directed CTP to refrain from issuing MGOs for the flavored Glas ENDS products (PM0004879.PD1-PM0004879.PD4).
Requester: Sean Greenbaum - Glas, Inc.
Dear Sir/Madam, I would like to request a copy of the disclosable portions of the decisional memorandum and/or other documentation reflecting the FDA's evaluation and determination regarding the eligibility of the following product for 5-year new chemical entity exclusivity: IZERVAY (AVACINCAPTAD PEGOL SODIUM, SOLUTIO…
Requester: Komal Patel - Dr. Reddy's Laboratories Inc.