Setter: A FOIA Getter
22623 requests collected across all agencies
FF Requests: 2025-8901; 2025-8903; 2025-11817; 2025-12955; 2025-12742
Requester: Nancy Silverman
FF Requests: 2025-13315; 2025-13317; 2025-13617; 2025-14049; 2024-8023
Requester: Nancy Silverman
the dosing usage and side effect of Lupron Depot
Requester: Jeffrey Williams - Veterinary Service
The form 483 inspection report or state equivalent generated from the MDRH (center) Medical Devices & Rad Health (product area) inspection of the following US facility in the month of February, 2026: - Onyx Medical, LLC dba Elos Medtech, 1800 Shelby Oaks Dr N, Bartlett, TN, 38134-7445, United States - Operation date, …
Requester: Mike Williams - The Capitol Forum
The form 483 inspection report or state equivalent generated from the HF (center) Foods (product area) inspection of the following US facility in the month of February, 2026: - Arctic Glacier USA Inc, 322 Vine St, Syracuse, NY, 13203-3132, United States - Operation date, report date, (last) date of inspection and / or…
Requester: Mike Williams - The Capitol Forum
The form 483 inspection report or state equivalent generated from the PHRM (center) Human Drugs (product area) inspection of the following US facility in the month of February, 2026: - InvaGen Pharmaceuticals, Inc., 7 Oser Ave, Hauppauge, NY, 11788-3811, United States - Operation date, report date, (last) date of insp…
Requester: Mike Williams - The Capitol Forum
The form 483 inspection report or state equivalent generated from the BIOL (center) Biologics (product area) inspection of the following US facility in the month of February, 2026: - Vericel Corporation, 25 Blue Sky Dr, Burlington, MA, 01803-2770, United States - Operation date, report date, (last) date of inspection …
Requester: Mike Williams - The Capitol Forum
The form 483 inspection report or state equivalent generated from the PHRM (center) Human Drugs (product area) inspection of the following foreign facility in the month of February, 2026: - Eugia Pharma Specialities Limited, 34 - 40 41p 44 - 48 Plot No: 4, Unit - Iii; Ida, Pashamylaram, India - Operation date, report …
Requester: Mike Williams - The Capitol Forum
The form 483 inspection report or state equivalent generated from the BIOL (center) Biologics (product area) inspection of the following US facility in the month of February, 2026: - Novartis Pharmaceuticals Corporation, 220 E Hanover Ave, Morris Plains, NJ, 07950-2445, United States - Operation date, report date, (la…
Requester: Mike Williams - The Capitol Forum
The form 483 inspection report or state equivalent generated from the PHRM (center) Human Drugs (product area) inspection of the following US facility in the month of February, 2026: - Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company, Rd # 686, Km # 2.3, Sector Cotto Norte, Bo. Tierras Nuevas, Manati, PR, 0…
Requester: Mike Williams - The Capitol Forum
The form 483 inspection report or state equivalent generated from the PHRM (center) Human Drugs (product area) inspection of the following US facility in the month of February, 2026: - Lonza Biologics, Inc., 101 International Dr, Portsmouth, NH, 03801-2846, United States - Operation date, report date, (last) date of i…
Requester: Mike Williams - The Capitol Forum
The form 483 inspection report or state equivalent generated from the BIOL (center) Biologics (product area) inspection of the following foreign facility in the month of February, 2026: - Valneva Scotland Ltd., Oakbank Park Road, Livingston, United Kingdom - Operation date, report date, (last) date of inspection and /…
Requester: Mike Williams - The Capitol Forum
The form 483 inspection report or state equivalent generated from the BIOL (center) Biologics (product area) inspection of the following US facility in the month of February, 2026: - Biomat USA, Incorporated, 2520 W 4700 S Ste A1, Taylorsville, UT, 84129-1873, United States - Operation date, report date, (last) date o…
Requester: Mike Williams - The Capitol Forum
The form 483 inspection report or state equivalent generated from the PHRM (center) Human Drugs (product area) inspection of the following US facility in the month of February, 2026: - Miyoshi America, Inc, 110 Louisa Viens Dr, Dayville, CT, 06241-1132, United States - Operation date, report date, (last) date of inspe…
Requester: Mike Williams - The Capitol Forum
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Microbiological Testing & Consulting, LLC Alsip, IL United States End Dates of inspection: 16 Sep 2025 FEI: 3003875820 Project Area: Drugs Classification: OAI I confirm that Clari…
Requester: Molly Bowman - Clarivate Analytics Espana (SAU)
1) Case ID: 26473104. Suspect Product Active Ingredients: Nicotine; Cyamemazine; Alcohol; Diazepam; Olanzapine; Cocaine; Propofol; Tramadol Hydrochloride; Midomafetamine; Tenamfetamine; Ketamine; Lidocaine; Cannabis Sativa Subsp. Indica Top; Acetaminophen. Reactions: Metabolic Acidosis; Withdrawal Syndrome; Coma; Sinu…
Requester: Lilly Holm - PharmaLex Denmark
I request a copy of Form 483 for Hubei Biocause Heilen Pharmaceutical Co., Ltd., Jingmen, China (FEI ID: 3007268407), for the inspection concluded on Nov 14, 2025.
Requester: Ankit Kumar
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: OraLabs, Inc Parker, CO United States End Dates of inspection: 26 Sep 2025 FEI: 3001237145 Project Area: Drugs Classification: OAI I confirm that Clarivate Analytics will be charg…
Requester: Molly Bowman - Clarivate Analytics
K.C. Pharmaceuticals, Inc 3420 Pomona Blvd Pomona, CA 91768-3236 United States FEI 2026940 Form 483 for drugs inspection ending 8/28/24
Requester: Aidan Moore - Dry Eye Foundation
K.C. Pharmaceuticals, Inc 3420 Pomona Blvd Pomona, CA 91768-3236 United States FEI 2026940 Form 483 for drugs inspection ending 2/13/2023
Requester: Aidan Moore - Dry Eye Foundation
Please send all inspection related documents release in March 2026. Inspection related documents are Form 483s and SEIR/EIRs.
Requester: Miea Hicks - POLITICO, LLC
Request for previously released inspection records namely Form 483s, Responses and EIRs, under the Freedom of Information Act (FOIA), as per the guideline.
Requester: R. Gulati - Regunalys LLC
Good Day! Based on the inspection listing we requested and received from the FDA, kindly please provide the following inspection-related documents in electronic PDF Format: The 483 (in electronic format) for the Human Drugs inspection of Lonza Biologics, Inc., located at 101 International Drive, Portsmouth, NH 03801, …
Requester: Joshua Boloy - Redica Systems
Good Day! Based on the inspection listing we requested and received from the FDA, kindly please provide the following inspection-related documents in electronic PDF Format: The 483 (in electronic format) for the Human Drugs inspection of Bristol-Myers Squibb Holdings Pharma, Ltd. Liability Company, located at Carr 686…
Requester: Joshua Boloy - Redica Systems
Good Day! Based on the inspection listing we requested and received from the FDA, kindly please provide the following inspection-related documents in electronic PDF Format: The 483 (in electronic format) for the Human Drugs inspection of ONY Biotech Inc., located at 1576 Sweet Home Road, Amherst, NY 14228, United Stat…
Requester: Joshua Boloy - Redica Systems
A copy of an approved Suitability Petition, Docket No. 1985P-0412. Solvay’s Suitability Petition for change in strength of Pyridostigmine tablets from 60 mg to 30 mg tablets was approved on January 22, 1986 (Docket No. 1985P-0412) and currently it is not available in FDA Petition Docket. I plan to submit an ANDA for 3…
Requester: Lisa Apolis - Apolis Regulatory Consulting,
Request for Approved Documents of Table-1 • Dexamethasone Sodium Phosphate, Solution/Drops, Ophthalmic, Otic, EQ 0.1% Phosphate • (neomycin and polymyxin B sulfates and dexamethasone Ophthalmic Suspension) 0.1%; EQ 3.5mg Base/mL;10,000 Units/mL • BSS® Sterile Irrigating Solution (balanced salt solution)
Requester: Dr. Rajender Singh - Mankind Pharma Ltd
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Island Kinetics, Inc. d.b.a. CoValence Laboratories Arizona United States End Dates of inspection: 23 Jan 2026 FEI: 3002408934 Project Area: Drug Quality Assurance Classification:…
Requester: Molly Bowman - Clarivate Analytics
Please send Form 483 for Galderma’s inspection around Relfydess (relabotulinumtoxinA, long acting botox). The facility to check is their Uppsala, Sweden or Baie-D’Urfé, Canada locations. The FDA issued a CRL for their application on October 3rd 2023 citing CMC issues, so assuming the manufacturing facility inspection …
Requester: Manushi Shah - Guidepoint Insights
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Naval Medical Center Portsmouth Virginia United States End Dates of inspection: 25 Sep 2025 FEI: 1176859 Project Area: Blood and Blood Products: Biologics Classification: VAI I co…
Requester: Molly Bowman - Clarivate Analytics
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Olgam Life LLC New York United States End Dates of inspection: 29 Oct 2025 FEI: 3025180180 Project Area: Blood and Blood Products: Biologics Classification: VAI I confirm that Cla…
Requester: Molly Bowman - Clarivate Analytics Espana (SAU)
483 issued to MicroBiopharm Japan Co., Ltd.,Iwata, Japan (FEI: 3003992082) on FDA Drug Inspection (260213)
Requester: Mari Yonomoto - Office YM
We are seeking Spartan Chemical company's (FEI No. 100257699, located 1110 Spartan Dr Maumee, OH 43537-1725) redacted Form 483, under Manufacturer establishment inspected type. Inspection end on Nov 21, 2025.
Requester: Xiaomei Han - Aelion AI Inc
5:49 AM Good Day! Based on the inspection listing we requested and received from the FDA, kindly please provide the following inspection-related documents in electronic PDF Format: The 483 (in electronic format) for the Human Drugs inspection of Novartis d.o.o., located at Kolodvorska Cesta 27, Menges, 1234, Slovenia,…
Requester: Joshua Boloy - Redica Systems
This request seeks FDA authored scientific and regulatory records concerning Teriparatide (Forteo), New Drug Application NDA 021318, originally approved on November 26, 2002. The purpose of this request is to obtain records that explain the clinical development pathway and the regulatory reasoning underlying FDA appro…
Requester: HOOMAN ASBAGHI
Freedom of Information Act request for FDA regulatory review records concerning Filgrastim (Neupogen), Biologics License Application BLA 103353, originally approved February 20, 1991. This request seeks FDA authored scientific and regulatory records explaining the clinical development pathway and regulatory reasoning …
Requester: Hooman Ambagi
Freedom of Information Act request for FDA regulatory review records concerning Epoetin alfa (Epogen and Procrit), Biologics License Application BLA 103234, originally approved June 1, 1989. This request seeks FDA authored scientific and regulatory records explaining the clinical development pathway and regulatory rea…
Requester: HOOMAN ASBAGHI
Freedom of Information Act request for FDA regulatory review records concerning Pegfilgrastim (Neulasta), Biologics License Application BLA 125031, originally approved January 31, 2002. This request seeks FDA authored scientific and regulatory records explaining the clinical development pathway and regulatory reasonin…
Requester: Hooman Asbaghi
I request copies of records related to any Pre-ANDA Product Development Meeting request, grant or acknowledgment letter, and official meeting minutes concerning oral semaglutide tablets (14 mg, 7 mg, and 3 mg) referencing Rybelsus (NDA 213051), from January 1, 2024 to the present. Please include records associated wit…
Requester: Junhee Kim - Junhee Kim
I am writing to request information under the Freedom of Information Act (5 U.S.C. § 552). I am seeking access to the following records: Requested Records: Full case reports and all associated documentation for the following Case ID numbers: Case ID: 26576954 Case ID: 26554893 Case ID: 26544799 I am requesting complet…
Requester: Gladys Gonzalez - Insmed Incorporated
PAI is the applicant of Promethazine DM Oral Solution (Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution), 6.25 mg / 15 mg per 5 mL (ANDA 040649). When PAI accepted ownership of this ANDA, a commitment was made to FDA to request the missing ANDA information that the previous applicant did not …
Requester: Billie J. Wiltison - PAI Holdings, LLC dba Pharmace
I would like records pertaining to the approval of the below listing in 21 CFR 176.170(b)(2), including the internal FDA Review Memorandum for this listing. Styrene polymers made by the polymerization of any combination of styrene or alpha methyl styrene with acrylic acid, methacrylic acid, 2-ethyl hexyl acrylate, met…
Requester: Shelly Prebay - Trinseo LLC
I am requesting FAERS Individual Case Safety Report including redacted narrative, for the following FAERS Case ID 26409679. Suspect drug Melphalan Hydrochloride- case initially submitted by Gland Pharma (US-GLANDPHARMA-US-2026GLNSPO00076)
Requester: Elizabeth Dempsey - United BioSource Corporation
Freedom of Information Act request for FDA regulatory review records concerning Etanercept (Enbrel), Biologics License Application BLA 103795, originally approved November 2, 1998. This request seeks FDA authored scientific and regulatory records explaining the clinical development pathway and regulatory reasoning und…
Requester: HOOMAN ASBAGHI
Please provide the following 1 inspection-related document in electronic PDF format: The Form 483 (in electronic format) for PMC Isochem, Gennevilliers, France FEI: 3002807312, inspection that happened in Feb 2017
Requester: Prateek Srivastava
Please provide the following 1 inspection-related document in electronic PDF format: The Form 483 (in electronic format) for Gland Pharma Limited, Hyderabad, India FEI: 3002647489, inspection that happened in July 2025
Requester: Prateek Srivastava
Please provide the following 1 inspection-related document in electronic PDF format: The Form 483 (in electronic format) for Jiangsu Hengrui Pharmaceuticals Co., Ltd., Lianyungang, China FEI: 3011603969, inspection that happened in April 2025
Requester: Prateek Srivastava
All previously released 483s and EIRs that were sent via Box in March 2026.
Requester: Global Key Solutions - Global Key Solutions
FF Request 2026-1326
Requester: John Lee - John Lee
Complete FAERS case report narratives — including all versions, follow-up submissions, and attachments — for twelve cases (See attached letter).
Requester: Desmond Butler - White Mountain Films