Setter: A FOIA Getter
22623 requests collected across all agencies
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Biologics inspection of Clinical Laboratories of HI at Wilcox Mem Hospital (Lab), located at 3420 KUHIO HWY, LIHUE, HI 96766-1048, United States, inspection ending 5/09/2025 (FEI 1000100792). The …
Requester: Jhan Ray Barril - Redica Systems
Dear FOIA Officer, Pursuant to the Freedom of Information Act (5 U.S.C. §¿552), I respectfully request access to the publicly releasable portions of the New Animal Drug Application (NADA #141-518) for Simparica Trio, manufactured by Zoetis Inc. and approved on March 2, 2020. Specifically, I am requesting copies of the…
Requester: Jacob T. T Borodovsky
De novo records related to DEN240062 (Device Name: Minder System) PMA records related to P820012 (Device Name: Cosman ICP Tele-Sensor)
Requester: Natalia Lopez - Kitea Health Ltd
I would like to ask for the final labeling (user manual/instructions for use) confirmed by the US FDA for the following 510(k) submission: K233253 Trade/Device Name: eCARTv5 Clinical Deterioration Suite ("eCART") Regulation Number: 21 CFR 870.2210 Regulation Name: Adjunctive Predictive Cardiovascular Indicator Regulat…
Requester: Harry Hyung Tak Han - AITRICS Co., Ltd.
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Biologics inspection of Rapa Therapeutics LLC, located at 12712 ROCK CREEK MILL RD STE 5B, ROCKVILLE, MD 20852-2574, United States, inspection ending 6/02/2025 (FEI 3016599369). The 483 (in electr…
Requester: Jhan Ray Barril - Redica Systems
Please share the Form 483 for INTECH Medical SAS Inspection ended on Apr 11, 2024 for the site Rang-Du-Fliers, France and fei id 3002904345. The inspection was related to Medical Device and Rad Health.
Requester: Sonika Shinghal - Sovish
FOIA Request – Drug Residue Testing and Sampling of Imported Aquaculture Seafood (2023-Present) Pursuant to the Freedom of Information Act (5 U.S.C. § 552), I respectfully request access to records related to veterinary drug residue testing of imported aquaculture seafood, specifically farmed finfish and crustaceans, …
Requester: Laura Cascada - Better Food Foundation
Ambu would like to request the full 510(k) file for K241612 issued to Hunan Vathin Medical Instrument Co. Ltd. Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2)
Requester: Sanjay Parikh - Ambu Inc.
I am requesting the full 510(k) file for K250096 as it was submitted, any and all correspondence that occurred between the applicant and FDA during the review, and any and all updates, amendments, supplements, changes, etc. to the 510(k) made by the applicant during the review.
Requester: Amanda Johnston - Gardner Law PLLC
My name is Zaur Abilov and I am a postdoctoral research fellow at the Beth Israel Deaconess Medical Center, Boston, Massachusetts. I submit this request in a personal capacity, based on a professional interest in the regulatory impact of peer-reviewed scientific publications.I am the first author of the research artic…
Requester: Zaur Abilov
Requesting the Summary Basis of Approval for NDA 216665 for the approval of VYKAT XR on 3/26/2025 from Soleno Therapeutics.
Requester: Terrie Kellmeyer - Aardvark Therapeutics
Please provide Multi-Discipline Review document for sNDA 215383/S-006 approving efficacy- a new indication: WELIREG for the treatment of adult patients with advanced renal cell carcinoma following a programmed death receptor-1 or programmed death-ligand 1 inhibitor and a vascular endothelial growth factor tyrosine kin…
Requester: Maryam Ansari - Arcus Biosciences
Please provide the current investigator's brochure (IB) for Burkinsa and Jaypirca. These documents are updated each year and include information about current and completed clinical studies.
Requester: Eric Sloan
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 request i…
Requester: Amanda Teitsort
Requesting 2 validated analytical methods (full method and validation report) used for fenbendazole residue studies in cattle for NADA 128-620, Panacur 10% oral suspension for beef and dairy cattle: 1. Cattle Liver marker residue analytical method for parent fenbendazole Approved on 2 Sept 1983. An established toleran…
Requester: - Chanelle Pharmaceuticals Manufacturing Ltd.
Bioequivalence study data submitted in support of ANDA approval for Unichem Pharmaceuticals’ guanfacine hydrochloride 1¿mg immediate-release tablet and Ajanta Pharmaceuticals guanfacine hydrochloride 1¿mg immediate-release tablet referencing Tenex® as the RLD in both cases.” Please provide: • Final bioequivalence stud…
Requester: Saadet Ulas Acikgoz - Saadet Ulas Acikgoz
The form 483 inspection generated from the BIOL/Biologics inspection of the following foreign facility in the month of April, 2025: MSD International GmbH,2025-04-11,Brinny, Innishannon,Co. Cork,Ireland,(TCF8n67radf007k).
Requester: Mike Williams - The Capitol Forum
Pursuant to the Freedom of Information Act (“FOIA”), 5 U.S.C. §§ 552 et seq., and regulations thereunder, I hereby request that you make available to me all records specified below, including the final report and any accompanying appendices. The two reports are cited in the (1) May 5, 2023 Freedom of Information Summa…
Requester: Morgan, Lewis & Bockius LLP
We seek the number of Complete Response Letters issued by year for the years 2022, 2023, and 2024 for CDER.
Requester: Lachman Consultants
2025-4177, 2025-4178, 2025-4179, 2025-4182, 2025-4183
Requester: Sonika Shinghal - Sovish
2025-4011, 2025-4013, 2025-4014, 2025-4015, 2025-4016
Requester: Sonika Shinghal - Sovish
Medtronic Visualase’s V2 submission (K250307); Freedom of Information (FOI) request for the corresponding submission content and correspondence, and the associated FDA reviewer's Notes, Memos, Letters, emails and/ or correspondence for the 510k submission, between the dates of 04/30/2025 and 06/10/2025
Requester: Monteris Medical
We Laboratoire CCD are requesting access to specific records related to our 510(k) clearance K894259 for our medical device: RIGISTER device, that we manufacture. In particular, we seek: -A copy of the original 510(k) submission file for K894259, including s and product code assignment documentation; -Any internal FDA…
Requester: Rym KACI - LABORATOIRE CCD
NDA 217806 SUPPL-13 for Zepbound- new indication in obstructive sleep apnea approved 20 December 2024 - Requesting all application review files for this Supplemental application.
Requester: Barbara Finn - Barbara Finn
All available documents related to 510k #K242610
Requester: - FOIA Document Source
2025-4012, 2025-4180, 2025-4630
Requester: Sonika Shinghal - Sovish
2025-3661, 2025-3662, 2025-3718, 2025-3783, 2025-3784
Requester: Sonika Shinghal - Sovish
2025-3302, 2025-3445, 2025-3495, 2025-3496, 2025-3552
Requester: Sonika Shinghal - Sovish
2025-3209, 2025-3210, 2025-3234, 2025-3242, 2025-3243
Requester: Sonika Shinghal - Sovish
510(k) Number: K233747 Device Name: Concha Sol Hearing Aids (CL-1001) Applicant: Concha Labs
Requester: Tomoko Asagami - Globizz
Could you please share any communications between the FDA and Hims & Hers Health, Inc since January 1st 2024?
Requester: Greenvale Capital
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Biologics inspection of Primary Children's Hospital, located at 100 N Mario Capecchi Dr, Salt Lake City, UT, 84113-1103, United States, inspection ending 4/17/2025 (FEI 3016665655). The 483 (in el…
Requester: Redica Systems
I would like to see correspondence with Eli Lilly regarding this statement in their labeling. I would also like to see if they provided any data or mechanisms of action regarding these reproductive damages in juvenile rat. Animal Data — Significant toxicity on muscle tissue, neurobehavior, reproductive organs, and bon…
Requester: Evan Alexander
Hi, I am requesting access to records maintained by the U.S. Food and Drug Administration relating to the Inactive Ingredient Database (IID) for the years 2000 through 2009. Specifically, I am seeking: Archived versions of the Inactive Ingredient Database (IID) or any equivalent datasets, records, or documents that in…
Requester: Sprigings IP
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Medical Devices inspection of DRG Instruments GmbH, located at Frauenbergstr. 18, Marburg, Germany, inspection ending 11/07/2024 (FEI 3002800697). The 483 (in electronic format) for the Medical De…
Requester: Redica Systems
EIR for April 2018 FDA Inspection Medical Devices Establishment: QUEST MEDICAL IMAGING Westrak 3 Wieringerwerf Noord-Holland, NL 1771SR Registration Number: 3010590422 FEI Number*: 3010590422 Status: Active Date of Registration Status: 2025
Requester: Olympus Corporation of America
K110962, AMBU ASCOPE 2
Requester: Gina Crossetta
We request the full unredacted version of the following documents 510k file K002381 AINN requests for more information and responses from the review.
Requester: Health Line International Corp
I would like to receive a copy of the "Statement" for K231060, Promin Dental Desensitizing Gel, Belport Company, Inc., as this PDF document cannot be opened on the FDA website. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231060
Requester: Globizz Corporation
I am seeking all information regarding a maude adverse event report made that resulted in the death of my son Bennett Spangler. MDR report key - 21539826 MDR text key - 365162633 Report # MW5167344
Requester: Caleb Spangler
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Medical Devices inspection of PAJUNK GMBH MEDIZINTECHNOLOGIE, located at Karl-Hall-Str. 1, Geisingen, Germany, inspection ending 2/06/2025 (FEI 3002807847). - Thank you!
Requester: Redica Systems
This is a formal request under the Freedom of Information Act (5 U.S.C § 552) for records related to WEB™ Embolization System (manufacturer: Terumo Neuro). Device Identification: •Manufacturer: Terumo Neuro •PMA number: P170032 •Approval date: 12-31-2018 Request Information •Technical documentation (performance testin…
Requester: LuSeed Vascular
I’m writing to request access to any emails sent or received by FDA official JOHN A. ELTERMANN that refer to the manufacturing or production of SPIKEVAX and COMIRNATY, vaccines for Covid-19. I request these emails under the U.S. Freedom of Information Act, 5 U.S.C. § 552, et seq. and I do so in my capacity as a freela…
Requester: David Willman
Dear FOIA Officer, Pursuant to the Freedom of Information Act, 5 U.S.C. § 552, and the implementing FOIA regulations of the the agency, I respectfully request the following: From the timeframe of January 20, 2021 through January 19, 2025, all of the following records from JOHN VERBETEN - [FORMER] DEPUTY DIRECTOR FOR I…
Requester: Mike Howell - The Daily Signal
All communications to and from Audrey Gassman regarding meningioma and medroxyprogesterone acetate.
Requester: Tracy Magnotta
Please provide available information for 510(k) K242323 (maestro system (ref100), Moon Surgical)
Requester: AKTORmed GmbH
All of the documents and records pertaining to the certification, accreditation, surveys, investigation, revocation of certification, performance, reviews, clinical image quality, and any other matter pertaining to the mammography facility known as the Wes and Jan Houser Women's Pavilion operated by Freeman Health Cen…
Requester: Johnson Vorhees & Martucci Law Firm
Results from the FDA’s testing of over-the-counter and prescription benzoyl peroxide acne treatments for benzene since January 1, 2024.
Requester: Bloomberg News
Please provide a copy of Class II DeNovo #DEN240023, amendments and associated correspondence for my own organizational records. The DeNovo Applicant is ClearPoint Neuro, Inc. from Solana Beach, CA 92075. The device name is SmartFlow Neuro Cannula (Product Code: SDG), which is intended for intraputaminal administratio…
Requester: Conventus Biomedical Solutions, Inc.
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: South Bend Medical Foundation, Inc. Indiana, United States End Dates of inspection: 01 Aug 2025 FEI: 1870308 Project Area: Blood and Blood Products Classification: VAI I confirm t…
Requester: Molly Bowman - Clarivate Analytics Espana (SAU)