Setter: A FOIA Getter
22623 requests collected across all agencies
Please provide me with records showing the FDA’s findings in the tests they conducted attached in the email below
Requester: Jamieson A. Andrew Leto
I'm requesting any written communications between representatives of Arnold Ventures and representatives of the Food and Drug Administration between May 1, 2025 and Dec. 30, 2025.
Requester: Gerry Smith - Bloomberg News
This is a first party request for our Establishment Inspection Report. Allison Medical Inc. (FEI Number 1000138447) was Inspected between 4/25/2023-4/28/2023. The inspection end date was 4/28/2023 and the 483 issued has been uploaded as First Party Documentation. Location of the inspection of Allison Medical Inc. is 8…
Requester: Mike Medina - Allison Medical Inc.
I hereby request copies of the following records related to Telix Pharmaceuticals Limited and its investigational product TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab): (i) The Complete Response Letter (CRL) issued by the FDA to Telix Pharmaceuticals Limited in August 2025 regarding the Biologics License Application (BL…
Requester: Zachary Stanco - The Rosen Law Firm, P.A.
Dear Sir/Madam, I would like to request Quality discipline review summary for Liraglutide Solution; Subcutaneous – 18 mg/3 mL (6 mg/mL). ANDA- A214568, Applicant - TEVA PHARMACEUTICALS DEVELOPMENT INC. ANDA approved on Aug 27, 2025. If you have any question or need further assistance to expedite this request, you can …
Requester: Jaya Lakshmi Ayyagari - Dr. Reddy's Laboratories Inc.
o We request a copy of all cosmetic facility registration and product listing records received under section 607(c) of the FD&C Act (MoCRA). From December 18, 2023, when the program was established, through December 31, 2025. Including facility registration records on facility name, address, FEI number, product catego…
Requester: Bridget Corridon - Personal Care Products Council
Information relating to: Product Manufacturer: MedWORX Laser Systems c/o Uriah Kennedy Device Name: MedWORX HPHD Evanlas 65W980nm Diode Therapy Laser 501K Number: K142078 Specifically: (1) Section 510(k) Premarket Notification submissions (including but not limited to: the proprietary name of the device, the generic n…
Requester: Britt DeVaney - Redgrave LLP
Requesting an attachment referenced in an FDA chemistry review memorandum for ICI Americas, Inc.’s, subsequently Victrex USA, Inc.’s, Food Additive Petition (FAP) 2B4333. This is a follow up to a request I placed in Sept. 2025 that was FDA FOIA 2025-11109 Specifically, I request Attachment 1 to Dr. Allan Bailey’s June…
Requester: Lauree Valverde - FOIA Request Services, LLC
Pursuant to the Freedom of Information Act (5 U.S.C. § 552), I respectfully request access to and copies of the complete administrative file associated with 510(k) submission K251904 (VascuChek® Clinical and VascuChek® Surgical). Please include, to the extent not exempt from disclosure: • The full 510(k) submission an…
Requester: Carla R. Scarmazzi, Specialist - King & Spalding LLP
Please provide the following inspection-related document in electronic PDF format: The 483 (in electronic format) for the Animal Health inspection of Zhejiang Dayang Biotech Group Co. Ltd., located at No. 22 Chaoyang Road, Dayang, Zhejiang 311616, China, inspection ending 11/20/2025 (FEI 3009493201). Thank You!
Requester: Jhan Ray Barril - Redica Systems
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Medical Devices inspection of Chirp Innovation, LLC, located at 3900 N Traverse Mountain BLVD STE 300, Lehi, UT 84043-5600 United States, inspection ending 11/21/2025 (FEI 3020769982). The 483 (in…
Requester: Joshua Boloy - Redica Systems
EIR for Medical Device Inspection completed 12/14/2023 at Intuitive Surgical, Inc. FEI # 3001675293.
Requester: Norma Ojeda-Sueiro - Intuitive Surgical Inc.
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Medical Devices inspection of Turbett Surgical, Inc., located at 245 Summit Point Dr Ste 2A, Henrietta, NY 14467-9608 United States, inspection ending 11/06/2025 (FEI 3012421755). The 483 (in elec…
Requester: Jhan Ray Barril - Redica Systems
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Medical Devices inspection of Rockwell Medical, Inc, located at 30142 S WIXOM RD, Wixom, MI 48393-3440 United States, inspection ending 11/20/2025 (FEI 3001236991). The 483 (in electronic format) …
Requester: Jhan Ray Barril - Redica Systems
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 November, 2025: - Biomat USA Inc, 4006 E Stan Schlueter Loop, Killeen, TX, 76542-8438, United States - Operation date, report date, (last) date of inspect…
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: Advanced RX Pharmacy of Tennessee LLC Tennessee United States End Dates of inspection: 06 Sep 2024 FEI: 3017450153 Project Area: Drugs Classification: VAI I confirm that Clarivate…
Requester: Molly Bowman - Clarivate Analytics
I am requesting the complete Summary Review, Clinical, Statistical, and Clinical Pharmacology reviews, as well as the Chemistry/Device and Quality reviews for Ryaltris (Olopatadine Hydrochloride and Mometasone Furoate) Nasal Spray, 665 mcg / 25 mcg, approved under NDA 211746. Our company is a pharmaceutical firm based…
Requester: young-eun yang - SAMA PHARM CO., 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: Blaine Labs Inc California United States End Dates of inspection: 22 Dec 2025 FEI: 3001744192 Project Area: Drugs Classification: OAI I confirm that Clarivate Analytics will be ch…
Requester: Molly Bowman - Clarivate Analytics
I am requesting the complete Summary Basis of Approval (SBA) and all available original review packages (including Medical, Statistical, and Clinical Pharmacology reviews) for Famvir (Famciclovir: 125mg, 250mg, 500mg), approved under NDA 020363. Our company is a pharmaceutical firm based in South Korea that handles Fa…
Requester: young-eun yang - SAMA PHARM CO., 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: Ehsan Sadri, M.D. California United States End Dates of inspection: 16 Apr 2025 FEI: 3027872855 Project Area: Bioresearch Monitoring: Drugs Classification: OAI I confirm that Clar…
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: Simtra BioPharma Solutions Westphalia Germany End Dates of inspection: 26 Sep 2025 FEI: 3002806419 Project Area: Drugs Classification: OAI I confirm that Clarivate Analytics will …
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: Patcos Cosmetics Pvt India End Dates of inspection: 18 July 2025 FEI: 3009250196 Project Area: Drugs Classification: OAI I confirm that Clarivate Analytics will be charged accordi…
Requester: Molly Bowman - Clarivate Analytics
A copy of approved label for NDA 219131, Duloxetine hydrochloride capsule delayed release pellets, 80 mg, 90 mg and 120 mg approved on Feb 27, 2026
Requester: AJANTA PHARMA LTD - Ajanta Pharma Ltd.
I am requesting information under the Freedom of Information Act (5 U.S.C. § 552). I am seeking access to the following record: Case ID - 26618503 (Brinsupri/Bensocatib), full case report(s) and all associated documentation. I am requesting complete case files including, but not limited to: Initial case reports follow…
Requester: Gladys Gonzalez - DSPV Operations and Vendor Management - Insmed Incorporated
I am requesting to receive copies of the 483 inspection report for the location listed below: Firm Name: Lonza Biologics Address: 101 International Drive, Portsmouth, NH 03801 Inspection Date: 2/6/26 FEI Number: 3001451441 Commodity: Human Drugs Please provide the documents electronically by email if possible.
Requester: Kristen Sellers - FOIA Professional Services
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 November, 2025: - Genzyme Flanders, Cipalstraat 8, Geel, Belgium - Operation date, report date, (last) date of inspection and / or date issued: 11/07…
Requester: Mike Williams - The Capitol Forum
Dear Sir/Madam, I would like to request following FDA 483: Document Type:FDA 483 Inspection Duration: September, 2025 - September, 2025 Site:Bio-Thera Solutions, Ltd. [Huangpu / China] FEI:3017231337 Investigator(s): Rose Xu, Yun Wu, PhD, Jie He, Christina Farris Thanks and regards Eric
Requester: Fred Fre
Please share the form 483 (and or EIR) of inspection generated from the PHRM/Human Drugs inspection of the following foreign facility in the month of July, 2025: Siegfried El Masnou, S.A.,2025-07-11,C Camil Fabra 58,El Masnou,Spain
Requester: Alessandro Carrino
Dear Madam/Sir, i would request for the following two documents: 1. 483 Document Type: FDA 483 Inspection Duration: March, 2025 - March, 2025 Site: FUJIFILM Diosynth Biotechnologies Texas, LLC [College Station / United States of America] FEI: 3011948449 Investigator(s): Zhong Li, PhD, Ayyappan Rathakrishnan, Jie He, M…
Requester: Fred Fre
I am requesting copies of records held by the Center for Drug Evaluation and Research (CDER) regarding the drug Lypressin, marketed under the trade name Diapid (New Drug Application NDA 16-755). Specifically, I am requesting the following: - Summary Basis of Approval: All medical, pharmacological, statistical reviews,…
Requester: John Kollins - John Kollins
Can I get a copy of the protocol and statistical analysis plan for clinical trial: NCT04314934 I understand that federal regulations require this information to be made public after one year of the trial completing, which was 8/9/2024. Applicable regulations are: 42 CFR 11.44 42 CFR 11.52 § 11.48(b) or https://www.ecf…
Requester: Jesse Brodkin - Behavioral Instruments
Excel Vision FEI 3007058211 Address Zone Industrielle, 27 Rue De La Lombardiere Annonay, Ardeche 07100 France Requesting drug inspection 483 from 11/19/24 inspection.
Requester: Aidan Moore - Dry Eye Foundation
FDA FOIA Request Requesting an Establishment Inspection Report (EIR) Requester Information • Requester Name: Sarah Ehnis • Title/Organization: Sr. Director, Global Quality Compliance & Analytics ; Emergent BioSolutions • Email Address: ehniss@ebsi.com • Mailing Address: 3500 N. Martin Luther King Jr. Blvd. Lansing, MI…
Requester: Sarah Ehnis - Emergent BioSolutions
I am writing with this request under the Freedom of Information Act (“FOIA”) seeking certified copies of the summary basis for approval and/or the Office of Generic Drugs Approval Routing Summary for both tentative and final approval of Abbreviated New Drug Application No. 219115, held by Alembic Pharmaceuticals Limit…
Requester: Stephanie Smith - Roberts Law Firm US, PC
FAERS Case ID: 26468221, 26533188, 26585657, 26574654, 24971159, 26606606, 26360043
Requester: Laura COTOROS-PETRULIAN - SERVIER PHARMACEUTICALS LLC
Re: NDA/BLA Number: 761371 (Ocrevus Zunovo) Seeking an explanation/documentation as to why PMR 4689-1 and 4689-2 have a current status of "Pending" and "Explanation of Status" of: "The study has not been initiated,but does not meet the criterion for delayed"; why PMR 4689-3 has a current status of "Pending"; and why P…
Requester: Kaylin M. Bower
This is a request under the Freedom of Information Act. I am requesting a complete electronic copy of the administrative file for Investigational New Drug Application (IND) 121764, originally submitted by MAST Therapeutics and subsequently associated with Savara Inc. The request includes all submissions, amendments, s…
Requester: John Lunger - LifeRaft Biosciences
Please share the Form 483 for SCIARRA AEROMED, INC. Inspection details: • End Date: Feb 25, 2026 • Site: SCIARRA AEROMED, INC, Carmel, United States • FEI Number: 3031372449
Requester: Sonika Shinghal - Sovish
NDA011459; VISTARIL (Hydroxyzine Pamoate) Capsules, 25 MG and 50 MG: Please provide container labels for below NDCs 25 mg: 100’s (NDC 0069-5410-66) 50 mg: 100’s (NDC 0069-5420-66)
Requester: Shipra Patel - Sandoz Inc.
I am requesting to receive copies of the 483 for the locations listed below: 1. ELAIAPHARM [Valbonne / France] Location: ZI BOUILLIDES, VALBONNE, PROVENCE ALPES COTE 06560, FRANCE (FRA) FEI: 3005659648 Inspection End Date: 01/30/2026 Industry: Human Drugs 2. Zennova Pharmaceuticals (chengdu) Co.,ltd. [Shuangliu / Chin…
Requester: Kristen Sellers - FOIA Professional Services
This FOIA request concerns NDA 018565 for Infumorph (morphine sulfate intrathecal injection). I am requesting the Summary Basis of Approval and all FDA review documents associated with this NDA, including but not limited to the medical review, statistical review, pharmacology/toxicology review, clinical pharmacology r…
Requester: Wesley Park - C Flow Labs Incorporated
Please provide an unredacted copy of the BLA Multi-Disciplinary Review and Evaluation memo for the sBLA for Jan 2021 FDA accelerated approval of DARZALEX FASPRO for light chain (AL) amyloidosis (This document is available for the initial approval of DARZALEX FASPRO in multiple myeloma, but not available for light chai…
Requester: Gabriel Morris - Nexcella, Inc.
Pharma Journalist looking for details on the observations after the inspection at Ajanta Pharma's facility Inspection date: from April 13th, 2026, to April 21, 2026 Location: Paithan, in Aurangabad, Maharashtra, India FEI Number of facility is either of the following: 3006785788/ 3015952830 inspection closed with the …
Requester: Meryl Dsouza - ET Now- Times Network
Form 483 for Azico Biophore India Private Limited located at Plot No: 40/A, J.N.Pharma City, Parawada Mandal, Anakapalli, Andhra Pradesh 531021, India (IND) (FEI#: 3010823443) for FDA Inspection that concluded on or about September 5th, 2025.
Requester: Gregor Stasik - XGen Pharmaceuticals DJB
We would like to request the form 483 from the 1/22/26 drugs inspection (1297654) of Excel Vision (FEI 3007058211) at Zone Industrielle, 27 Rue De La Lombardiere, Annonay, Ardeche 07100 France.
Requester: Aidan Moore - Dry Eye Foundation
Dear Sir/Madam, I would like to request Final Labeling approved in Suppl- 019 for Sunlenca (lenacapavir), injection NDA 215973/S-019 and Suppl- 014 for Sunlenca (lenacapavir), tablets, NDA 215974/S-014. Applicant - GILEAD SCIENCES INC. Suppl-19 (N 215973) and supply-14 (N215974) Approved on 03/12/2026. If you have any…
Requester: Komal Patel - Dr. Reddy's Laboratories Inc.
Form 483 for MAHI DRUGS PRIVATE LIMITED located at Plot No. 82, J.N. Pharma City, Parawada, Anakapalli, Andhra Pradesh 531019, India (IND) (FEI#: 3019853340) for FDA Inspection that concluded on or about January 24th, 2025.
Requester: Gregor Stasik - XGen Pharmaceuticals DJB
All communications between the FDA and Johnson&Johnson regarding COVID vaccines.
Requester: Brooke Conrad - Spotlight on Maryland
Dear Madam / Sir, I'm writing on behalf of Dr. Emil Benatov & Partners Patent and TM Bureau. Please provide an official document sufficient to show whether the U.S. Food and Drug Administration has ever approved any human drug product containing such a substance as nefopam or nefopam hydrochloride in the United States…
Requester: Daniel Benatov - Patent and TM Bureau Dr. Emil
Form 483 for Lonza's production site in Visp, Switzerland.
Requester: Patrick Rafaisz - UBS