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 |
|---|---|---|---|---|---|---|---|
| Unipack LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Guangxi Yulin Pharmaceutical Group Co. Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Novo Nordisk Inc. | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded | … blame yourself? 0:30:59.780 --> 0:31:2.50 Yeah, it's two fold when you're the mom. And that's why when you said … | ||||
| Eli Lilly and Company | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded | … blame yourself? 0:30:59.780 --> 0:31:2.50 Yeah, it's two fold when you're the mom. And that's why when you said … | ||||
| CCIC Huatongwei International Inspection Co., Ltd. | Center for Devices and Radiological Health | Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies | |||||
| United King Foods Private Limited | Human Foods Program | Low Acid Canned Food Regulation/Adulterated |
|||||
| International Laboratories Corp | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceutical/Adulterated | |||||
| Red Oak Instruments, LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | |||||
| Filler Lux dba Filler Lux USA | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
… o “Areas of Application: Chest: Anterior axillary fold in women, fat in men Cellulite Treatment Back: … | ||||
| Julian Naya Beauty LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |