Warning Letters
Learn about the types of warning letters on FDA's website.
- Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter.
- To obtain additional available information, contact FDA. Requests to FDA for agency records should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5630 Fishers Lane, Rockville, MD 20857. Instructions for how to submit an FOI request can be found at How to Make a FOIA Request.
- Frequently requested records may be accessed on the Reading Room page.
| Posted Date | Letter Issue Date | Company Name | Issuing Office | Subject | Response Letter | Closeout Letter | Excerpt |
|---|---|---|---|---|---|---|---|
| Las Americas Supermercado#2 Inc. | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | … Las Americas Supermercado#2 Inc. … 09/24/2025 WARNING LETTER Re: CMS # 716877 Dear Mr. Antonio Perez: From 08/28/2025 to 09/08/2025, the Food and Drug Administration (FDA) conducted … | ||||
| Diasol, Inc. | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | … of your firm located in Phoenix, AZ from July 21, 2025, through August 19, 2025, investigators from the United … under Drum Cleaning Validation (Protocol #75.007, dated 09/04/2019). The reusable (b)(4) drums are cleaned with … request. iii. Data for re-validation dated 10/09/2020 using (b)(4) drums showed conductivity and pH tests … | ||||
| Aytu Biopharma | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded | … … Aytu Biopharma … WARNING LETTER September 9, 2025 Dear Josh Disbrow: As part of its monitoring and … CARTER M BEACH 09/09/2025 05:08:26 PM On behalf of George Tidmarsh, M.D., Ph.D … | ||||
| Aytu Biopharma | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded | … … Aytu Biopharma … WARNING LETTER September 9, 2025 Dear Josh Disbrow: As part of its monitoring and … CARTER M BEACH 09/09/2025 05:08:14 PM On behalf of George Tidmarsh, M.D., Ph.D … | ||||
| Alora Pharmaceuticals | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded | … /s/ CARTER M BEACH 09/09/2025 05:14:50 PM On behalf of George Tidmarsh, M.D., Ph.D … | ||||
| Eli Lilly and Company | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded | … CARTER M BEACH 09/09/2025 05:18:14 PM On behalf of George Tidmarsh, M.D., Ph.D … (last accessed date September 8, 2025) 7 This information is for background purposes only and … | ||||
| Eli Lilly and Company | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded | … about access, LillyDirect, and Zepbound vials.” 3:50-4:09: Interviewer: “Thank you so much to the both of you and … appeared on Fox25’s “Living Oklahoma” website on July 11, 2025. FDA has determined that the video is false or … CARTER M BEACH 09/09/2025 05:09:22 PM On behalf of George Tidmarsh, M.D., … | ||||
| Eli Lilly and Company | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded | … appeared on Dayton247 Now’s “Your Day” website on July 9, 2025. FDA has determined that the video is false or … CARTER M BEACH 09/09/2025 05:09:35 PM On behalf of George Tidmarsh, M.D., Ph.D … | ||||
| Novo Nordisk Inc. | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded | … Thoughts … Novo Nordisk Inc. … WARNING LETTER September 9, 2025 Dear Maziar Mike Doustdar: The U.S. Food and Drug … CARTER M BEACH 09/09/2025 05:18:24 PM On behalf of George Tidmarsh, M.D., Ph.D … |