Setter: A FOIA Getter
22623 requests collected across all agencies
calendar records for FDA-CVM employee Charlotte Conway, dates 09.01.25-10.31.25
Requester: Kohl Harrington - Harrington Films
On behalf of Noble Innovations LLC, I respectfully submit this request under the Freedom of Information Act (5 U.S.C. § 552) to obtain documentation from the FDA’s Center for Devices and Radiological Health (CDRH) concerning the Silverlon Antimicrobial Wound Dressing (510(k) Number K141033) submitted by Argentum Medic…
Requester: Dimitrije Stojanovski - Noble Innovations LLC
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Biologics inspection of Bavarian Nordic A/S, located at Hejreskovvej 10A, Kvistgaard, Denmark 3490, Denmark (DNK), inspection ending 11/07/2023 (FEI 3008318564). The 483 (in electronic format) for…
Requester: Jhan Ray Barril - Redica Systems
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Biologics inspection of 2seventy bio, Inc., located at 60 Binney STREET, Cambridge, Massachusetts (MA) 02142, United States (USA), inspection ending 03/20/2025 (FEI 3020975594). The 483 (in electr…
Requester: Jhan Ray Barril - Redica Systems
Pursuant to the Freedom of Information Act, I hereby request the following records for the following California Cryobank LLC facilities from January 1995 - November 2025. FEI: 3005342355 FEI: 3001236834 FEI: 3003367577 FEI: 3005202248 This request encompasses all inspections conducted under FDA Compliance Program 7341…
Requester: Alexis Clay - Alexis Clay
Pursuant to the Freedom of Information Act, 5 U.S.C. § 552, and the implementing regulations under 21 C.F.R. Part 20, Cogency Global Inc. hereby requests a copy of the following: • Chemistry, manufacturing, and controls (CMC) review of the supplemental application submitted in December 2024 and approved in April 2025 …
Requester: Joanna McCall - COGENCY GLOBAL INC.
To whom it may concern, The following request is being made in accordance with the Freedom of Information Act (5 U.S.C. § 552). I am requesting copies of the following records: All FDA Form 3038s for Shellfish dealer/shipper Frenchman Bay Oyster Company, LLC from January 1, 2021, through October 16, 2025 filed with th…
Requester: Kathleen Casey - Strategic Records Research
Please provide all records relating to K874154 Elecath Transesophageal Pacing Catheter cleared 4/29/1988. Include all correspondence, reviewers notes, and 510(k) contents. Thank you!
Requester: Melissa Walker - Graematter Inc
Pursuant to the Freedom of Information Act, 5 U.S.C. § 552, Allstate Insurance Company is requesting access to and copies of any and all records related to the attached document dated October 30, 2019 that identifies the following: Product Manufacturer: MedWORX Laser Systems c/o Uriah Kennedy Device Name: MedWORX HPHD…
Requester: Melissa Davis - Allstate Insurance Company
Consumer complaint that was filed with the CDRH’s Allegations of Regulatory Misconduct Branch 12-11-2024 and was given CPT file number (CPT2402274)
Requester: Christian Aguilera-Sandoval
All documents related to De Novo Submission DEN220078 related to Eroxon
Requester: Abhishek Gurnani - Amin Wasserman Gurnani LLP
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Food and Cosmetics inspection of Phi Sciences, located at 1695 E Cottonwood St Ste N, Cottonwood, AZ, 86326-4560, United States, inspection ending 8/22/2025 (FEI 3001970179). The 483 (in electroni…
Requester: Jenny Adarog - Redica Systems
Complete Response Letter (CRL) issued on August 27, 2025 for Telix Pharmaceuticals Limited's BLA submission of Zr89-girentuximab.
Requester: Pharmalogic Pharmalogi - Pharmalogic
All notes, emails, letters, memos, recordings or other FDA records associated with the regulatory meeting held with Empower Pharmacy on 05/04/2023. I ask that all responsive documents be sent in electronic format.
Requester: Julian Gill - Houston Chronicle
I request all records related to the voluntary recall of Clover Valley® Instant Coffee (8 oz., UPC 876941004069; lots L-5163, L-5164, L-5165; best-by Dec 13–14, 2026) by Dollar General due to potential glass contamination. Specifically, I request: The completed Voluntary Recall Action Plan or equivalent recall submiss…
Requester: Anand Anan
Pursuant to the Freedom of Information Act, 5 U.S.C. § 552, and the implementing regulations under 21 C.F.R. Part 20, Cogency Global Inc. hereby requests all records related to the June 6, 2022, FSVP inspection of a strawberry distributor connected to the 2022 and 2023 hepatitis A in strawberries outbreak, including b…
Requester: Joanna McCall - COGENCY GLOBAL 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: Fargo VA Healthcare System North Dakota, United States End Dates of inspection: 13 Jun 2025 FEI: 1777411 Project Area: Blood and Blood Products Classification: VAI I confirm that …
Requester: Molly Bowman - Clarivate Analytics Espana (SAU)
Good Day! We kindly request the following inspection-related documents in electronic PDF format: The 483R and Establishment Inspection Report (EIR) for the Animal Health inspection of DSM Nutritional Products, LLC, located at 495 Jackson Concourse, Pendergrass, GA 30567-4648 United States, inspection ending 06/12/2025…
Requester: Jhan Ray Barril - Redica Systems
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Biologics inspection of UW - Madison Health Sciences IRB, located at 800 University Bay Dr Ste 105, Madison, WI 53705-2299 United States, inspection ending 07/25/2025 (FEI 2126201). The 483 (in el…
Requester: Jenny Adarog - Redica Systems
Records of all communications between the FDA and Empower Pharmacy, including letters, emails and notes of phone calls, regarding FAERS Case ID 16668267.
Requester: Julian Gill - Houston Chronicle
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Biologics inspection of GlaxoSmithKline Biologicals, located at 10 Tuas South Avenue 8, Singapore, Singapore, inspection ending 08/05/2025 (FEI 3016007176). The 483 (in electronic format) for the …
Requester: Jhan Ray Barril - Redica Systems
Under the Freedom of Information Act (5 U.S.C. § 552), I hereby request a copy of the non-confidential portions of the 510(k) submission for K081512 — StealthViz Advanced Planning Application (Medtronic Navigation, Inc.). Specifically, I request the following materials in electronic format (PDF preferred): The 510(k) …
Requester: Feng Chen
The 483 (in electronic format) for the Food and Cosmetics inspection of MERICON INDUSTRIES, INC., located at 8819 N. Pioneer Road, Peoria, Illinois (IL) 61615, United States (USA), inspection ending 08/21/2024 (FEI 1450054). The 483 (in electronic format) for the Food and Cosmetics inspection of American Cruise Lines,…
Requester: Jenny Adarog - Redica Systems
Good Day! We kindly request the following inspection-related documents in electronic PDF format: The 483R and Establishment Inspection Report (EIR) for the Medical Devices inspection of Medtronic Xomed, Inc., located at 6743 Southpoint Dr N, Jacksonville, FL 32216-6218, United States, inspection ending 06/17/2024 (FEI…
Requester: Jhan Ray Barril - Redica Systems
Please see attached request letter
Requester: OFT Law - OFT Law
This request is for the Complete Response Letter issued to Telix Pharmaceuticals, on or about August 28th, 2025. The product in question is ZIRCAIX (girentuximab) for which a BLA was reviewed within CDER, most likely by the Division of Imaging and Radiation Medicine (DIRM).
Requester: Warren Cooper - HealthCare Royalty
FOIA Request: I am requesting a copy of BridgeBio Pharma’s response to the FDA’s letter dated September 9, 2025, concerning its Direct-to-Consumer marketing for Attruby, including the television commercial featuring Morgan Freeman. The letter cited violations related to false or misleading promotional claims under the…
Requester: Lara Amoroso
The form 483 inspection report or state EIR generated from the BIOL/Biologics inspection of the following foreign facility in the month of August, 2025: - Roche Diagnostics GmbH, Nonnenwald 2, Penzberg, Germany - Operation date, report date, (last) date of inspection and / or date issued: 08/01/2025 - The Capitol Foru…
Requester: Mike Williams - The Capitol Forum
The form 483 inspection report or state EIR generated from the BIOL/Biologics inspection of the following foreign facility in the month of August, 2025: - GlaxoSmithKline Biologicals, 10 Tuas South Avenue 8, Singapore, Singapore - Operation date, report date, (last) date of inspection and / or date issued: 08/05/2025 …
Requester: Mike Williams - The Capitol Forum
The form 483 inspection report or state EIR generated from the BIOL/Biologics inspection of the following foreign facility in the month of August, 2025: - Takeda Manufacturing Singapore Pte. Ltd., 2a Woodlands Industrial Park D, Singapore, Singapore - Operation date, report date, (last) date of inspection and / or dat…
Requester: Mike Williams - The Capitol Forum
The form 483 inspection report or state EIR generated from the BIOL/Biologics inspection of the following US facility in the month of August, 2025: - Element Materials Technology Boston - Acton Inc., 33 Nagog Park, Acton, MA, 01720-3421, United States - Operation date, report date, (last) date of inspection and / or d…
Requester: Mike Williams - The Capitol Forum
The form 483 inspection report or state EIR generated from the BIOL/Biologics inspection of the following US facility in the month of August, 2025: - CSL Plasma Inc., 2650 North Ave, Grand Junction, CO, 81501-6405, United States - Operation date, report date, (last) date of inspection and / or date issued: 08/07/2025 …
Requester: Mike Williams - The Capitol Forum
The form 483 inspection report or state EIR generated from the BIOL/Biologics inspection of the following US facility in the month of August, 2025: - SAFC Carlsbad Inc., 6219 El Camino Real, Carlsbad, CA, 92009-1604, United States - Operation date, report date, (last) date of inspection and / or date issued: 08/14/202…
Requester: Mike Williams - The Capitol Forum
The form 483 inspection report or state EIR generated from the BIOL/Biologics inspection of the following US facility in the month of August, 2025: - Grifols Diagnostic Solutions, INC., 10808 Willow Ct, San Diego, CA, 92127-2408, United States - Operation date, report date, (last) date of inspection and / or date issu…
Requester: Mike Williams - The Capitol Forum
Request for documents and information regarding Hologic Inc.’s JustRight 5mm Surgical Stapler.
Requester: John D. Blakely - Dunn Sheehan LLP
I request copies of all documents in the possession of FDA, from July 1, 2025 – September 30, 2025, regarding products sold under the following names: Jamieson Jamieson Wellness Nutricorp Nutrawise Smart Solutions Body Plus Progressive Precision Iron Vegan youtheory Including any: a) Form FDA 3500 Voluntary Reporting,…
Requester: Sherry Mowbray - Jamieson Laboratories Ltd.
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Animal Health inspection of Peptech Animal Health PTY Limited, located at 19-25 Khartoum Rd, Macquarie Park, Sydney, N.S.W. 2113, Australia, inspection ending 11/11/2022 (FEI 3002886659). The 483 …
Requester: Jhan Ray Barril - Redica Systems
Please see attachment.
Requester: Theodore David - Grant & Eisenhofer
Hello,There is a device, Combicath, which was pulled from the market. The original filer was Prodimed LLC back on March 13th, 1998. I am looking for all documents related to their filing, and anything else related. Please let me know and thank you for your assistance.Best, Mike
Requester: Michael Seip - KOL Biomedical Instruments LLC
A Copy of the Establishment Inspection Report (EIR) for inspection of: AOMORI OLYMPUS CO., LTD. 2-248-1 OKKONOKI KUROISHI-SHI Aomori, JP 036-0357 Registration Number: 9614641 FEI Number*: 3003995201 July 11, 2022 to July 14, 2022
Requester: Robert Fryc - Olympus Corporation of the Ame
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483: Vitti Labs, LLC, Missouri, United States End Dates of inspection: 15 Mar 2024 FEI: 3015365441 Project Area: Compliance: Human Cellular, Tissue, and Gene Therapies Classification: …
Requester: Molly Bowman - Clarivate Analytics Espana (SAU)
We represent the foreign exporter Zhanjiang Xinhui Aquatic Food Co. Ltd. Please see the attached Letter of Authorization. We are requesting the administrative file and any relevant documents that pertain to Xhinhui's placement on Import Alert # 16-124.
Requester: Jessica Calafiore - Olsson Frank Weeda Terman Matz
A copy of the Summary Basis of Approval for BLA 761034/S-009, approved on December 12, 2018, for TECENTRIQ (atezolizumab).
Requester: Aisha Evans - Hyman, Phelps & McNamara, P.C.
On the publicly available FDA site: https://www.fda.gov/media/119312/download, FDA provides a list of companies participating in the FDA Foreign Supplier Verification Programs. We request a spreadsheet which includes the 23 publicly available data points for all entries that led to La Lorraine Bakery Usa LLC's inclusi…
Requester: Richard Anturiano-Chavez - Registrar Corp
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Biologics inspection of Grifols Diagnostic Solutions, INC., located at San Diego, United States of America, 10808 WILLOW CT, SAN DIEGO, CA, 92127-2408, UNITED STATES, inspection ending 2025-08-26 …
Requester: Jenny Adarog - Redica Systems
Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Biologics inspection of Takeda Manufacturing Singapore Pte. Ltd., located at Singapore, Singapore, 2A WOODLANDS INDUSTRIAL PARK D, SINGAPORE, 737779, SINGAPORE (SGP), inspection ending 2025-08-15 …
Requester: Jenny Adarog - Redica Systems
Shipment ID 799-9703977-1/21/1 & 799-3786219-2/61/1 import refusal details - namely tracking number, shipper and recipient. Currently showing on FDA Supplier dashboard for FEI 3009150119 as import refusals. These shipments look to be adulterated individual patient packs shipped to the US containing multiple different …
Requester: Wendy Whitfield - Recipharm Pharmaservices Priva
I received permission to apply rTMS in my clinic on everyday patients back in 1999 - this was somehow facilitated by Tony Morris of Neotonus. Unfortunately, I have lost the documents. Please help me ! Back then, the clinic was located at 720 Osterman Ave in Deerfield, IL 60015
Requester: Steve Best - Steven R. Devore Best, MD
Under the Freedom of Information Act, 5 U.S.C. 552, I respectfully request a copy of the complete 510(k) premarket notification file for 510(k) number K210259.Please include the 510(k) Submission, Summary, decision letters, and any supporting documents that are releasable under FOIA.To expedite processing, I am reques…
Requester: Ryan Hobson - BISCO, Inc.
I am seeking to request all required FDA documents for my grandpa's business ITG Medev. FDA approval documents, foreign trade documents etc. We need these documents to put into our new eQMS system.
Requester: Ryan Roberts - ITG Medev