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 |
|---|---|---|---|---|---|---|---|
| Good Girl LLC dba GoodGirlRX | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | … Good Girl LLC dba GoodGirlRX … WARNING LETTER February 20, 2026 … | ||||
| Eli Lilly and Company | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded | … my kids out in public. I felt like I was not being a good mother. I didn't leave my house. I didn't talk to my … and you just don't eat. You go to the gym and you'll be good. Oprah: 0:10:45.150 --> 0:11:0.740 And you know what? … people like me that if you had told me when I was a little girl that I would be sitting here talking about those … | ||||
| Novo Nordisk Inc. | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded | … my kids out in public. I felt like I was not being a good mother. I didn't leave my house. I didn't talk to my … and you just don't eat. You go to the gym and you'll be good. Oprah: 0:10:45.150 --> 0:11:0.740 And you know what? … people like me that if you had told me when I was a little girl that I would be sitting here talking about those … | ||||
| Cooperstown Cheese Company, LLC | Division of Human and Animal Food Operations East I | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes | … FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based … of a cutting board that was being used to cut RTE Jersey Girl cheese. Furthermore, dating back to 2017, your firm has … a sanitary environment during our next inspection. Current Good Manufacturing Practice (21 CFR Part 117, Subpart B): 1. … |