Setter: A FOIA Getter
22623 requests collected across all agencies
We are requesting case reports on the specified case numbers on toxicities/adverse effects associated with administration of Pluvicto (lutetium Lu 177 vipivotide tetraxetan). This request is via the Freedom of Information Act. The reason for the request is for academic purposes. As per our previous communication, we h…
Requester: John Villano - University of Kentucky Markey Comprehensive Cancer Center
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Scapa Tapes North America LLC Tennessee United States End Dates of inspection: 07 Feb 2020 FEI: 3015200795 Project Area: Drugs Classification: VAI I confirm that Clarivate Analyti…
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: Pharma Nobis LLC Texas United States End Dates of inspection: 13 Mar 2020 FEI: 1611206 Project Area: Drugs Classification: OAI I confirm that Clarivate Analytics will be charged a…
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: Vitae Enim Vitae Scientific, Inc. California United States End Dates of inspection: 22 Sep 2021 FEI: 3014384422 Project Area: Drugs Classification: OAI I confirm that Clarivate An…
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: Mylan, Inc. A Viatris Company Pennsylvania United States End Dates of inspection: 12 Dec 2025; FEI: 3042120103 Project Area: Drugs Classification: VAI I confirm that Clarivate Ana…
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: ULTRAtab Laboratories, Inc. New York United States End Dates of inspection: 31 Jan 2020 FEI: 3003068822 Project Area: Drugs Classification: OAI I confirm that Clarivate Analytics …
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: Steri-Pharma, LLC New York United States End Dates of inspection: 08 Aug 2025 FEI: 3008585015 Project Area: Drugs Classification: OAI I confirm that Clarivate Analytics will be ch…
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: Florida Suncare Testing Inc. Florida United States End Dates of inspection: 24 Jul 2025 FEI: 3009633124 Project Area: Drugs Classification: VAI I confirm that Clarivate Analytics …
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: Lonza Tampa LLC Florida United States End Dates of inspection: 22 Aug 2025 FEI: 3001549109 Project Area: Drugs Classification: VAI I confirm that Clarivate Analytics will be charg…
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: Derma Care Research Labs LLC Florida United States End Dates of inspection: 08 Aug 2025 FEI: 3013570706 Project Area: Drugs Classification: OAI I confirm that Clarivate Analytics …
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: Wexler Surgical, Inc. Texas United States End Dates of inspection: 30 Jul 2025 FEI: 1000160162 Project Area: Devices Classification: VAI I confirm that Clarivate Analytics will be…
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: Operating Room Innovations, Inc California United States End Dates of inspection: 22 May 2025 FEI: 3017838287 Project Area: Devices Classification: OAI I confirm that Clarivate An…
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: Precision Edge Surgical Products Company LLC. Michigan United States End Dates of inspection: 11 Jul 2025 FEI: 1000139987 Project Area: Devices Classification: VAI I confirm that …
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: QPS, LLC Delaware United States End Dates of inspection: 30 Jan 2026 FEI: 3003581184 Project Area: Drugs Classification: VAI I confirm that Clarivate Analytics will be charged acc…
Requester: Molly Bowman - Clarivate Analytics
Please share Form 483 for Sharp Sterile Manufacturing, LLC. Inspection details: • End Date: Mar 05, 2026 • Site: Sharp Sterile Manufacturing, LLC, Lee, United States • FEI Number: 3012144557
Requester: Shalu Shrotiya
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Walfer Corporation dba Wallace Pharmacy Florida United States End Dates of inspection: 16 Mar 2020 FEI: 3016458098 Project Area: Drugs Classification: OAI I confirm that Clarivate…
Requester: Molly Bowman - Clarivate Analytics
US1PR01546-Exparel Requesting EXPAREL Medwatches for the following cases: 26376535 26305029
Requester: Sarina Thapar - Cencora Global Consulting Serv
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 LICO Industries, LLC, located at 10390 Bermuda Ct, Mohave Valley, Arizona (AZ) 86…
Requester: Jhan Ray Barril - 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 L. Perrigo Company, located at 515 Eastern Ave, Allegan, Michigan (MI) 49010, Uni…
Requester: Jhan Ray Barril - Redica Systems
Please be advised our office represents Keisha Lavender with respect to a Vaccine Injury Compensation Program (VICP) claim to be filed in the U.S. Court of Federal Claims. This is not a medical negligence case or a product liability case. In short, the VICP is a no-fault alternative to the traditional tort system for …
Requester: Jeffrey S. S. Pop & Associates
Request for MedWatch Report for Product Case ID: 26310361 Suspect Product: Copiktra (Duvelisib) Reaction: Disease Progression Sex: Male Patient Age: Unknown
Requester: Gnana Velaga - UNITED BIOSOURCE LLC
Dear Sir/ Madam. Please provide copy of tentative approval letter for following: SEMAGLUTIDE (SEMAGLUTIDE) | ANDA #220314 | INJECTION;SOLUTION | Tentative Approval | APOTEX INC
Requester: Srinivas Gurram - Zydus Pharmaceuticals USA Inc.
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 - 26569536 (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 - Insmed Incorporated
Request for MedWatch Report for Product Case ID: 26545015 Suspect Product:Copiktra (Duvelisib) Reaction: Hospitalisation Sex: Female
Requester: Gnana Velaga - UNITED BIOSOURCE LLC
Request for MedWatch Report for Product Case ID: 26423907 Suspect Product: Copiktra (Duvelisib) Reaction: Pruritus; Product Use Issue Sex: Male Patient Age: Unknown
Requester: Gnana Velaga - UNITED BIOSOURCE LLC
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 January, 2018: - Medline Industries, LP, 1940 Commerce Dr, North Mankato, MN, 56003-1700, United States - Operation date, report date, (last) date of in…
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 January, 2018: - Medline Industries LP, 494 State Route 416, Montgomery, NY, 12549-2418, United States - Operation date, report date, (last) date of inspection …
Requester: Mike Williams - The Capitol Forum
A copy of the April 7, 2026 letter tentatively approving ANDA 220314 for Semaglutide Injection.
Requester: Jamerra Cherry - Hyman Phelps & McNamara, P.C.
I am requesting access to all records, communications, reports, or documentation related to any investigation, review, or administrative action involving me within HHS/FDA.
Requester: Min Wang
Please provide ALL 483s, EIR's, Responses and 510ks pdfs released to ANY requestor from 3.01.2026 thru 3.31.2026
Requester: Orca1 Orca - Orca1 Digital Intelligence, LL
I request a copy of Form 483 for Xiamen Kang Zhongyuan Biotechnology Co., Ltd., Xiamen, China (FEI ID: 3027976266), from the Human Drugs inspection concluded on Aug 15, 2025.
Requester: Ankit Kumar
FDA correspondence to Qilu Pharmaceutical Company ("Qilu") informing Qilu of its receipt of tentative approval for Qilu's Abbreviated New Drug Application No. 213499 for afatinib related to the brand drug Gilotrif.
Requester: George J. Barry III - Kratz & Barry LLP
Dear Sir/Madam, I would like to request Tentative Approval letter of SEMAGLUTIDE INJECTION;SOLUTION, 2.68MG/1ML, 8MG/3ML, 4MG/3ML, 2MG/1.5ML and 2MG/3ML. ANDA- 220314, Applicant – APOTEX INC. TA approval letter issued on April 07, 2026. If you have any question or need further assistance to expedite this request, you …
Requester: Komal Patel - Dr. Reddy's Laboratories Inc.
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 Medical Devices inspection of NDS Surgical Imaging LLC, located at 100 Paramount Dr Ste 101, Sarasota, FL 3…
Requester: Joshua Boloy - Redica Systems
I am requesting to receive copies of the 483 for the location listed below: Firm Name: Fresenius USA Manufacturing Firm Address: 475 W 13th Street, Ogden, UT 84404 FEI Number: 1713747 Commodity: Human Drugs Inspection Date: 3/6/26 Please provide the documents electronically by email if possible.
Requester: Kristen Sellers - FOIA Professional Services
As the MAH, Vertex Pharmaceuticals is requesting the complete unredacted source information available for FDA FAERS case ID# 26525030 (Product/Drug name: Journavx). Vertex Case ID: 2026-006225. Thank you.
Requester: David Jaimes (Dept: Global Patient Safety) - Vertex Pharmaceuticals
Request for MedWatch report for Product Case ID: 25390636, Suspect Product Active Ingredients: Prednisolone;Acetaminophen;Tocilizumab;Meropenem;Tebentafusp;Methylprednisolone, Reactions: Cytokine Release Syndrome;Drug Ineffective, Serious, Outcomes: Hospitalized;Other Outcomes;Life Threatening, Event Date: 24-NOV-2022…
Requester: Olivia Dahl - United BioSource LLC
We are requesting a copy of any/all of the following documents from the FDA inspection of the BioTek Statesboro GA facility (FEI 3021103110). Biomat USA acquired this location from Biotek and the center management does not have copies of these documents and we need to make sure we have these for our files. EIR Form 48…
Requester: Cheryl Webb - Biomat USA
To the FOIA Officer, 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 …
Requester: BYUNGSUN PARK
Requesting EIR for Inspection ID: 1207359 (Product type: Food / Cosmetics) with an End Date: 5/16/2023 for the following: Pylam Products Company, Inc. 2175 E Cedar St Tempe, AZ 85281-7431 United States FEI Number: 2410113 Thank you-
Requester: Matthew Shelton - Sheffield Pharmaceuticals
Attached in document
Requester: Jon Helander - Diadema Partners
Please share the Form 483 for below Inspection details : Site: ICON plc, Assen, Netherlands Inspection End Date: 10/24/2025 FEI Number: 3038011239 Site: ICON plc, Dublin, Ireland Inspection End Date: 05/24/2024 FEI Number: 3016465959 Site: ICON plc, Pennsylvania, United States Inspection End Date: 03/27/2025 FEI Numbe…
Requester: Neelima P - Infodesk Inc
I am an investment professional requesting the complete FAERS case records for Palsonify (paltusotine hydrochloride), case number 26372328. If available, please email both the Excel and PDF files to quinn.lin@sireniacap.com. Thanks!
Requester: Quinn Lin - Sirenia Capital
All final and/or tentative approval letters for Abbreviated New Drug Application (ANDA) No. 217590.
Requester: Amy Kennelly
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Freelance Formulations LLC Florida United States End Dates of inspection: 08 Feb 2023 FEI: 3014109782 Project Area: Drugs Classification: OAI I confirm that Clarivate Analytics wi…
Requester: Molly Bowman - Clarivate Analytics Espana (SAU)
Pursuant to the Freedom of Information Act, 5 U.S.C. § 552 (hereinafter the “FOIA”), and the Food and Drug Administration (“FDA”) implementing regulations, 21 C.F.R. Part 20 et seq., on behalf of Epstein Becker & Green, P.C., (“EBG”), I hereby make the following requests for the production of FTC records as outlined b…
Requester: George C. Whipple III - Epstein Becker Green
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 Richline Group Inc Florida United States End Dates of inspection: 16 Apr 2025 FEI: 3006749547 Project Area: Devices Classification: OAI 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: GC Hanford Manufacturing Company New York United States End Dates of inspection: 20 Mar 2025 FEI: 1310197 Project Area: Drugs Classification: OAI I confirm that Clarivate Analytic…
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: J. Robert Flamini Georgia United States End Dates of inspection: 11 Mar 2024 FEI: 3014137184 Project Area: Drugs Classification: OAI I confirm that Clarivate Analytics will be cha…
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: Ehsan NMI Sadri MD California United States End Dates of inspection: 16 Apr 2025 FEI: 3027872855 Project Area: Bioresearch Monitoring: Drugs Classification: OAI I confirm that Cla…
Requester: Molly Bowman - Clarivate Analytics