Setter: A FOIA Getter

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 Castellum, L.L.C's inclusion in this…

Requester: Richard Anturiano-Chavez - Registrar Corp

I respectfully request copies of the complete 510(k) files for Carefree panty liner products corresponding to the following FDA submissions: 1. K832382 2. K792195 3. K961119 4. K841311 5. K820522 This request is being made for my own personal and/or organizational records. Specifically, I am seeking the full 510(k) fi…

Requester: Sarkis Yenikomshuyan - The Vartazarian Law Firm

Dear FOIA Officer, Pursuant to the Freedom of Information Act, 5 U.S.C. § 552, I am requesting a copy of the FDA warning letter sent to Hims & Hers regarding marketing practices related to their compounded weight-loss drug product. This letter has been reported by The New York Times. Additionally, I request copies of …

Requester: Chris Murphey - Sinclair Broadcasting / Full M

FDA correspondence, both internal and external, discussing the safety and permissibility of using Safflower (American Saffron) as a coloring agent in food.

Requester: Michael Best (K. Nobert) - Michael Best

I would like to access the form 483 with observations issued for the following company. Name: Cronus Pharma Specialties India Pvt. Ltd Location: Sy. No: 99/1 Plot No. 9 (B) GMR Hyderabad Aviation Sez, Mamidipalli Village, Shamshabad Hyderabad, Telangana 500108, India. FEI number: 3015283219 Inspection End Date: 20 Aug…

Requester: Rama Lakshmi Killi - Learn About Pharma

The 510(k) summary associated with K894269.

Requester: Christopher Cocchiaraley - [no org]

Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Biologics inspection of KB Dental Products Inc, located at 22865 Savi Ranch Pkwy Ste H, Yorba Linda, CA - California, 92887-4626, US - United States of America, inspection ending 07/31/2025 (FEI 3…

Requester: Jhan Ray Barril - Redica Systems

1. All documents related to the Food and Drug Administration (“FDA”) investigation into the theft that occurred at Yale New Haven Hospital on or about January 31, 2022, reported on DEA Form 106 dated February 1, 2022 and amended February 3, 2022; copies of any reports related to that investigation, including any draft…

Requester: Brigid Tesla - Wiggin and Dana

K201207 - CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line - Fresenius Medical Care Renal Therapies Group, LLC; K233159 - pureFLO…

Requester: Nicolas Antih - Nextkidney B.V

Requesting the complete 510(k) file for ATMOS C 051 Thorax (K241799).

Requester: Gladiann Lugo Rodriguez - Centese

I would like to request copies of all releasable Form 3911s related to semaglutide or tirzepatide that have been filed since January 1 2024

Requester: Patrick Wingrove - Reuters

I am writing to request an update to prior FDA FOIA responses in which we received spreadsheets listing petitions for specific time periods. In those earlier requests, the spreadsheets included petitions all the way through December 2024. We now seek an updated spreadsheet that captures the same information for the pe…

Requester: Cindy Shearrer - University of Missouri School

Date Range of Requested Records: From: 01/01/2020 To: 09/02/2025 Subject: Pursuant to the Freedom of Information Act (5 U.S.C. § 552), I request copies of records, grant documentation, and communications regarding federally funded research conducted at the University of Texas MD Anderson Cancer Center, as well as FDA …

Requester: Daniel Rizzo

Pursuant to the Freedom of Information Act (FOIA), 5 U.S.C. 552, I hereby request copies of the following records related to Telix Pharmaceuticals Limited and its investigational product TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab):The Complete Response Letter (CRL) issued by the FDA to Telix Pharmaceuticals Limited in…

Requester: Roger Estafanos

To Whom It May Concern,Pursuant to the Freedom of Information Act, I respectfully request a copy of the Not-Approvable Letter issued by the FDA to enVVeno Medical Corporation regarding their Premarket Approval (PMA) application for the VenoValve device.If possible, please include any related correspondence or document…

Requester: Dario Arcuti - Technical University of Munich

We'd like to re3quest the full 510(k) submission for K233225, Device Name: SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) Applicant Name: Schoelly Fiberoptic GmbH

Requester: Rebecca Brophy - Intuitive Surgical, Inc.

Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Biologics inspection of Sher Fertility Solutions New York, located at 425 5th Ave Fl 3, New York, NY, 10016-2223, United States, inspection ending 07/22/2025 (FEI 3005202232). The 483 (in electron…

Requester: Jhan Ray Barril - Redica Systems

Full 510(k) submission for K990284, BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE

Requester: Jay Kelley - Kelley MedTech Consulting

I am writing to request access to records related to a food safety incident on Delta Flight 542 from Seattle to Atlanta on August 3, 2024. This incident involved a dead rodent found in a salad provided by Gate Gourmet, Inc. I am seeking the following records: 1. Inspection Reports: All inspection reports related to fo…

Requester: Maxwell Jones - Max Law, LLC

I request copies of all correspondences between the following AGC Biologics LLC manufacturing facilities and FDA including 483 letters, response letters, and warning letters from January 1, 2025 to the present. (1) 21511 23rd Dr. SE, Bothell, Washington 98021; (2) 5550 Airport Blvd, Boulder, CO 80301.

Requester: Shannon Moore - MPG Operations LLC

Request copy of 510(k)K240083 GORE PROPATEN Vascular GraftDecision Date: 03/01/2024Applicant: W.L. Gore & Associates Inc.Regulation Number: 870.3450Classification Code: DSYMedical Specialty: Cardiovascular

Requester: LaVonne Waldon - Paladin Medical, Inc.

Lab analysis report for entry 9XR-0025390-3 (item# BB0391GG and HK1328GG) filed by Champion Customs Broker, Inc. for Importer of Record Townley Inc. The samples were collected on 07/16/2025 and lab analysis and review was completed by 08/19/2025.

Requester: Enway Melo - Champion Customs Broker, Inc.

I am writing to request access to any correspondence between FDA and Eli Lilly regarding human variations in concentrations of selective serotonin reuptake inhibitors, specifically focusing on Prozac (fluoxetine) and any other SSRIs owned by Eli Lilly.

Requester: Evan Alexander

From the month of December 2023, all of the following records from Pratt, Robert D (Douglas.Pratt@FDA.HHS.GOV), SUPERVISORY MEDICAL OFFICER All congressional correspondence and communications to/from Congressional Offices or Committees for the previous month including responses or document productions to outstanding, …

Requester: Colin Aamot - The Daily Signal

Assessment sumary report of ANDA 216187

Requester: Changzhou Pharmaceutical Factory

We are seeking information related to a request we submitted to the Agency regarding "Thermal incidents involving Flum Float vaping devices on aircraft". On January 31, 2023, we submitted a letter to the Center for Tobacco Products flagging unfavorable trends involving products that appear to have been produced by Flu…

Requester: UL Standards & Engagement

PMTAs and Communications Pertaining to NJOY Daily Disposable Menthol E-Cigarettes

Requester: Womble Bond Dickinson (US) LLP

All documents and correspondence underlying the FDA's Marketing Denial Order for PM0002058.PD1 and PM0002058.PD3, dated June 24, 2024. This request includes, but is not limited to, the underlying TPLs, memorandums, and any other written analyses related to the Order. The requesting party, Fox Rothschild LLP, is an aut…

Requester: FOX ROTHSCHILD LLP

Under the U.S. Freedom of Information Act, I'm requesting the full supplemental New Drug Application submitted by Novo Nordisk for Wegovy on September 8, 2023.

Requester: CNN

1) Any/All facilities inspections at facilities in PA and CA Establishment Inspection Reports (EIRs), FDA 483s, Responses or Correspondence between the company and FDA related to those inspections. 2) Any Regulatory Meeting(s) with FDA CDRH with dates and Minutes/Notes/Handouts, etc. 3) Any Regulatory Meeting(s) with …

Requester: Deminor Recovery Services (USA) Inc.

Superior Environmental Consultancy requests any disclosable documents or portions of documents, or related information, (i.e., FDA internal memoranda, review or research notes, meeting notes, emails, and similar documents) pertaining to the FDA CTP’s position or possible position (or potential plans) related to tobacc…

Requester: Superior Environmental Consultancy, LLC

From January 1, 2020 to date, all email correspondence sent or received from Elizabeth Miller, to include attachments and calendar invites, with at least one of the following keywords or phrases: “unannounced inspection” “Foreign unannounced inspections pilots” "FUIP" “Short notice inspection"

Requester: ProPublica

I am requesting all information you have pertaining to backwoods cigars distributed by itg brands llc which use to be own by phillip reynolds tobacco company. The cigars are coming moldy with white and blue spores and green patches and are deceiving customers. They are robbing the american people and i need the inform…

Requester: Jarrell Curne

Agency: HHS > FDA - Food and Drug Administration [Reference FAST# 24- 83821 ] Relevant to FDA, we seek copies of the following: FDA Orphan Drug Designation Application for Tepotinib-NSCLC with MET genomic abberation CLEARLY RELEASABLE OK, $50 FEE APPROVAL

Requester: FOIA FAST LLC

Records that pertain to the surveillance, tracking, containment and prevention of H5N1 in dairy products, dairy cows and people that work closely with dairy cows, poultry or milk processing. This includes inspection records for dairy milk processing facilities in Idaho, Michigan, Texas, Colorado, New Mexico, North Car…

Requester: New Scientist

Approval and Regulatory History, Letters, Labels, Reviews for BLA 761037/S-013

Requester: Tourmaline Bio, Inc.

First-Party FOIA Request for Unredacted FDA Documents Related to May 3, 2024 Limited Marketing Denial Order for NicQuid LLC; STNs PM0003712.PD1, PD41-45, PD52-57, PD82-87, PD94-109

Requester: NicQuid LLC

Copies of the Technical Project Lead Review(s) associated with the Center for Tobacco Products’ (“CTPs”) issuance of a marketing denial order to Shenzhen Yibo Technology Co. Ltd. dated April 15, 2024, related to CTP’s review of the company’s Premarket Tobacco Product Application(s).

Requester: Kleinfeld Kaplan & Becker LLP

Under the Freedom of Information Act, I would like to request copies of FDA databases (or of reports taken from said databases) listing Form 3911s related to semaglutide (Wegovy, Ozempic, Rybelsus) and tirzepatide (Mounjaro) between January 1 2022 and the date the documents are sent.

Requester: REUTERS

Interested in summary letter, review data, predicate information and the compr testing completed for the 510k approval for the following 510K numbers: K214028 (Micor Lens Fragmentation System) K222236 (Micor System Lens Fragmentation System) K200584 (Xport 304 Micor System Lens Fragmentation System)

Requester: Andy Doraiswamy

Please send the communication for IDE 16949, numbers 004 and 006. Thank you

Requester: RegenLab USA

Under the Freedom of Information Act, 5 U.S.C .§ 552, I am requesting to obtain information regarding the following record: Please provide the disclosable portions of any more recent version of the CTP memoranda “Interdisciplinary OS State of the Science on Electronic Nicotine Delivery Systems (ENDS)” (Includes litera…

Requester: FOIA Professional Services, LLC

Copies of any documents (including correspondence and any Agency written assessments or determinations) concerning FDA's determination that there are potential problems associated with Ciprofloxacin HCl Tablets, 100 mg, which are sufficiently serious such that the drug should be removed from the market under 21 CFR 31…

Requester: Hyman, Phelps & McNamara, P.C.

A copy of all presentation materials used in the public workshop conducted by FDA on "Mitigation Strategies for Nitrosamine Drug Substance Related Impurities: Quality and Bioequivalence Considerations for Generic Products" on June 15, 2023 at The Universities at Shady Grove, Maryland.

Requester: Pistevo Law LLC

Please provide the following 1 inspection-related document in electronic PDF format: The EIR (in electronic format) for the Biologics inspection of Berkshire Sterile Manufacturing, Inc. located in Lee, MA, US - Inspection ending 2023-01-20 (FEI 3012144557). Please send documents as email attachments.

Requester: Redica Systems

Please provide the following 1 inspection-related document in electronic PDF format: The 483 Response (in electronic format) for the Biologics inspection of Berkshire Sterile Manufacturing, Inc. located in Lee, MA, US - Inspection ending 2023-01-20 (FEI 3012144557). Please send documents as email attachments.

Requester: Redica Systems

Interdisciplinary OS State of the Science on Electronic Nicotine Delivery Systems (ENDS)

Requester: Womble Bond Dickinson (US) LLP

Interdisciplinary OS State of the Science on Electronic Nicotine Delivery Systems (ENDS)

Requester: David Graham - NJOY, LLC

Interdisciplinary OS State of the Science on Electronic Nicotine Delivery Systems (ENDS) that includes literature through March 31, 2020.

Requester: Maria Perez - The Examination

I am requesting a copy of all the FDA Form 3911's that have been submitted to the FDA to-date.

Requester: University of Tennessee Health Science Center College of Pharmacy