Setter: A FOIA Getter
22623 requests collected across all agencies
Please provide details of following inspection:_x000D_ Glenmark Pharmaceuticals Monroe facility (FEI No. 3011585599) was inspected (GMP inspection) from 9 June 2025 to 17 June 2025 and was issued a Form 483 with five (5) observations. All the observations are procedural in nature. There was no observation related to d…
Requester: Amlan Jyoti Das - Nomura Financial Advisory and
Full 510(k) Submission Documents for K203634
Requester: Amir Torbati - Impressio Inc.
Please see attached request (HHS-FDA-25-1454)
Requester: American Oversight - American Oversight
Please see attached request (MULTI-25-1444-1452)
Requester: American Oversight - American Oversight
Subject: FOIA Request Submission – FDA Oversight on COVID-19 Vaccine Mandate Justification Dear FOIA Officer, I am submitting the attached FOIA request regarding FDA’s role in the authorization, emergency use decisions, and internal analysis surrounding COVID-19 vaccine mandates and their justification. This reque…
Requester: Amanda Teitsort
During review of the 2025 1st quarter FAERS files, case reports were identified that were not sent to Digestive Care, Inc. As the manufacturer of Pertzye (pancrelipase) drug product, we would like to request the following case report that lists Pertzye as the primary/secondary suspect. Case ID 24909947
Requester: Amanda Rennig - Digestive Care, Inc.
FDA Oversight on COVID-19 Vaccine Mandate Justification
Requester: Alyssia Collins - mctlaw
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of following._x000D_ 1. Gland Pharma Limited, located at Plot No: 49 & 50, J N Pharmacity, Parawada, Anakapalli, India, inspection ending 02/25/2025 (FEI 3010142300)_x000D_ …
Requester: Alpesh Patel - iPharmaSolutions LLC
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of following._x000D_ 1) David Berz, M.D., Ph.D, located at 2080 Century Park E Ste 803, Los Angeles, California (CA) 90067-2011, United States (USA), inspection ending 01/14…
Requester: Alpesh Patel - iPharmaSolutions LLC
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of following. _x000D_ 1. Apotex Pharmachem India Pvt Ltd., located at Plot 1a Bommasandra Industrial Area 4th Phase, Jigani Link Road, Bommasandra Ind. Estate, Bangalore, In…
Requester: Alpesh Patel - iPharmaSolutions LLC
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of following. _x000D_ 1. Acupac Packaging Inc, located at 55 Ramapo Valley Rd, Mahwah, NJ, 07430-1118, USA, inspection ending 14/03/2025 (FEI 2244725)._x000D_ 2. Acuity Spec…
Requester: Alpesh Patel - iPharmaSolutions LLC
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of following._x000D_ 1) Scientific Protein Laboratories, LLC, located at 700 E Main St, Waunakee, WI, 53597-1440, USA, inspection ending 02/05/2025 (FEI 2111173)._x000D_ 2) …
Requester: Alpesh Patel - iPharmaSolutions LLC
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of following._x000D_ 1) Sanofi-Aventis Deutschland GmbH, located at Industriepark Hochst, Bruningstr. 50, Frankfurt Am Main, Germany, inspection ending 01/16/2025 (FEI 30031…
Requester: Alpesh Patel - iPharmaSolutions LLC
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of following._x000D_ 1) Katarzyna Bartnicka Maslowska MD, located at Ul. Gruszowa 2, Lodz, Poland, inspection ending 01/04/2025 (FEI 3033256534). _x000D_ 2) Revance Therapeu…
Requester: Alpesh Patel - iPharmaSolutions LLC
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of following._x000D_ 1. The Ritedose Corporation, located at 1 Technology Cir, Columbia, SC, 29203-9591, USA, inspection ending 02/28/2025 (FEI 3001237796)_x000D_ 2. PLD Acq…
Requester: Alpesh Patel - iPharmaSolutions LLC
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of following. _x000D_ 1) Rebel Converting, LLC, located at 11225 W Heather Ave, Milwaukee, WI, 53224-2205, USA, inspection ending 02/24/2025 (FEI 3010166020)_x000D_ 2) A2A I…
Requester: Alpesh Patel - iPharmaSolutions LLC
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of following. _x000D_ 1) Summit Biosciences Inc., located at 1513 Bull Lea Rd, Lexington, KY, 40511-1200, USA, inspection ending 02/21/2025 (FEI 3007577023)_x000D_ 2) BPI La…
Requester: Alpesh Patel - iPharmaSolutions LLC
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of following._x000D_ 1) Diversified Chemical Products, Inc., located at 60 Germay Dr, Wilmington, DE, 19804-1105, USA, inspection ending 01/31/2025 (FEI 1000071265)._x000D_ …
Requester: Alpesh Patel - iPharmaSolutions LLC
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of following._x000D_ 1) Allergan Pharmaceuticals Ireland, located at Castlebar Road, Westport, Ireland, inspection ending 01/30/2025 (FEI 3002806285)._x000D_ 2) Alto ICP, LL…
Requester: Alpesh Patel - iPharmaSolutions LLC
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of following._x000D_ 1) Zhejiang Huahai Pharmaceutical Co., Ltd., located at Xunqiao Town, Linhai, China, inspection ending 01/24/2025 (FEI 3003999190)._x000D_ 2) Carolina I…
Requester: Alpesh Patel - iPharmaSolutions LLC
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of following._x000D_ 1) Merck Sharp & Dohme LLC, located at 2778 South East Side Hwy, Elkton, VA, 22827-3628, USA, inspection ending 01/22/2025 (FEI 1112271)._x000D_ 2) REGI…
Requester: Alpesh Patel - iPharmaSolutions LLC
483 issued to Sun Pharmaceutical Industries Ltd on 14 June 2025 for Halol manufacturing facility in Gujarat
Requester: Allison Villinski - GRT US Holding Inc
Summary Basis of Approval for Symbravo original NDA 21-5431 approved January 2025
Requester: Allison Villinski - GRT US Holding Inc
1. Inspections, warning letters, or compliance actions involving NY Blood Center. 2. Emails, memos, or meeting notes between FDA and NYBC staff.
Requester: Alex Bates
Laser Product Filings Involving NFL Stadium Use
Requester: Alan Amron
FOIA Request for Laser Device Safety Filings at NFL Stadiums
Requester: Alan Amron
request the EIR. Inspected Facility Information is as follows: InnoStar Bio-Tech Nantong Co. LTD 100 Dongtinghu Road, Qilinzhen Haimen Linjiang Town, Nantong, China FEI Number is: 3029550626 Inspection End Date: November 1, 2024 Inspection Type: Human Drugs (GLP)
Requester: Adrienne Xenos-Koehler - Novartis Institutes for Biomed
483R and a copy of 483 if it is available. Inspected Facility Information is as follows: InnoStar Bio-Tech Nantong Co. LTD 100 Dongtinghu Road, Qilinzhen Haimen Linjiang Town, Nantong, China FEI Number: 3029550626 Inspection End Date: November 1, 2024. Inspectin Type: Human Drugs (GLP)
Requester: Adrienne Xenos-Koehler - Novartis Institutes for Biomed
Subject: FOIA Request – 510(k) K230829 summary_x000D_ _x000D_ Dear FOIA Officer,_x000D_ _x000D_ Pursuant to the Freedom of Information Act, I hereby request a copy of the following documents related to 510(k) Premarket Notification K230829 summary:_x000D_ _x000D_ - 510(k) Summary (it not available online)_x000D_ _x…
Requester: Adam Huang - HIVOX BIOTEK INC.
The entire Biologics License Application, including but not limited to all data and information enumerated in 21 C.F.R. § 601.51(e)2 with the exception of publicly available reports on the Vaccine Adverse Events Reporting System,3 for the Novavax Vaccine.
Requester: Aaron Siri - Siri & Glimstad LLP
All manuals, policies, guidance, handbooks, directives, memos, notices, and standard operating procedures concerning Elsa (the artificial intelligence tool used by FDA).
Requester: Aaron Siri - Siri & Glimstad LLP
The entire Biologics License Application, including but not limited to all data and information enumerated in 21 C.F.R. § 601.51(e)2 with the exception of publicly available reports on the Vaccine Adverse Events Reporting System,3 for the Moderna Vaccine.
Requester: Aaron Siri - Siri & Glimstad LLP
All records concerning any and all adverse events that occurred during any clinical trial relied upon by FDA to lower the age of use for MenQuadfi (manufactured by Sanofi Pasteur, Inc.) to include individuals 6 weeks through 23 months of age. Information helpful to fulfilling the request: The approval to lower the age…
Requester: Aaron Siri - Siri & Glimstad LLP
All communications (including but not limited to emails, text messages, direct messages, Teams chats, Slack chats, Skype messages, Signal messages, WhatsApp messages, etc.) sent and/or received by R. Douglas Pratt, David Kaslow, Karin Bok, Peter Marks, and/or Vinay Prasad from July 1, 2024 through the date of the sear…
Requester: Aaron Siri - Siri & Glimstad LLP
All records concerning lowering the age of use for MenQuadfi to include individuals 6 weeks through 23 months of age. Responsive records include but are not limited to email and text communications, summary basis for approval, meeting minutes/notes/transcripts, slide decks, and documents created, modified, and/or shar…
Requester: Aaron Siri - Siri & Glimstad LLP
All clinical trial documents and data relied upon by FDA to lower the age of use for MenQuadfi (manufactured by Sanofi Pasteur, Inc.) to include individuals 6 weeks through 23 months of age. Information helpful to fulfilling the request: The approval to lower the age of use was granted on May 23, 2025. The agency may …
Requester: Aaron Siri - Siri & Glimstad LLP
FGI requests all records from December 1, 2022, until the date the search begins that meet the following criteria: • All communications of the custodians to, from, or including anyone at the Office of Management and Budget, the Office of Information and Regulatory Affairs, and the White House staff about regulation…
Requester: Functional Government Initiative
I am requesting to receive all form 483's issued to Esteve Quimica, S.A. in Banyeres del Penedes, Spain (ESP) from 1/1/24-present. FEIN number: 3006616345 Category: Human Drugs ¿If no Form 483’s were issued, please confirm if an inspection has occurred in that time frame but no 483’s were issued, or if no inspe…
Requester: Dana Powell
Consultation on 94 pages responsive to America First Legal v. HHS 1:23-cv-03680-CKK for records icluding the words “ivermectin,” “early (drug) treatment,” “early treatment,” “remdesivir,” or “horse.”
Requester: Reed Rubenstein - America First Legal
FDA Form 483 (Inspectional Observations) issued following the FDA inspection conducted at Aomori Olympus located in Aomori prefecture, Japan, from November 4 to November 7.
Requester: Keisuke Nakanishi
Dear Sir or Madam, We are writing to inform you that we believe some companies may be listing our organization as their U.S. Agent for cosmetic facilities and drug facilities without our knowledge or consent. Unlike food facilities and medical devices, where a formal system exists to accept or reject a U.S. Agent desi…
Requester: Pasquale Carvelli - Cosmereg LLC
This is a request under the Freedom of Information Act, 5 U.S.C. § 552. I request records previously released under FOIA related to the FDA’s 2022-2024 investigation of tara flour, and foodborne illness outbreaks associated with Daily Harvest and Revive Superfoods Products. Specifically I request copies of all records…
Requester: Paris Martineau - Consumer Reports
Requesting the EIR for Inspection ID: 1273626 (Product Type: Food/Cosmetics) with an end date of 08/26/2025 for the following company: Denison Pharmaceuticals, LLC 1 Powder Hill Rd Lincoln, RI 02865-4407 United States FEI Number: 1210580 Thank you-
Requester: Matthew Shelton - Sheffield Pharmaceuticals
I am requesting to obtain information regarding the following record: Contract Title: FDA NEXT GENERATION DATA CENTER HOSTING SOLUTION; RFP Number: FDARFI20241232202. I am requesting copies of the following information from the record detailed above: Contract and any Modifications; Performance Work Statement (PWS); St…
Requester: Elizabeth Mack - FOIA Professional Services
Dear officers, I am writing to request the complete dossiers for FCN 87 (1,4-Cyclohexanedimethanol). Thanks for your assistance. Best regards, Maxwell Song
Requester: Maxwell Song - REACH24H USA INC.
I am requesting the Cosmetic Facility Registrations and the Cosmetic Product Listings which have been submitted for each of the facilities listed below. These were submitted by a former Pak Technologies employee, Aaron Herzog. I am a Pak Technologies employee, requesting records on behalf of Pak Technologies as well a…
Requester: Caroline Davis - Pak Technologies
We request a spreadsheet detailing the number of Food Canning Establishments (FCE) that are registered with FDA in each country as of December 31, 2025, to include the name of the country and the number of Food Canning Establishments registered in that country. We also request the list for domestic registered faciliti…
Requester: Richard Anturiano-Chavez - Registrar Corp
I am requesting a copy of the Review in the Drug Approval Package for the New Drug VYKAT XR, NDA # 216665, approved 03/26/2025 for the Applicant SOLENO THERAPEUTICS.The approval letter and the labeling are on the Drugs@FDA: FDA-Approved Drugs website, but the review has not been included and this is the basis of my re…
Requester: Bruce Thompson - Reguliance LLC
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Animal Health inspection of Leach Livestock Auction, located at 5930 US HWY 412, Alt., Kansas, OK 74347 United States, inspection ending 06/03/2022 (FEI 3022844619). The 483 (in electronic format)…
Requester: Joshua Boloy - Redica Systems
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Animal Health inspection of Jordan J Weaver, located at 4650 E. 1300 N, Roann, IN 46974, United States, inspection ending 10/31/2025 (FEI 3040682068). The 483 (in electronic format) for the Animal…
Requester: Joshua Boloy - Redica Systems