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 |
|---|---|---|---|---|---|---|---|
| Jiangmen Shuizirun Sanitary Articles Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Hanlim Pharm Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Eurofins SF Analytical Laboratories, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Lewis Sausage Company Inc. | Center for Veterinary Medicine | CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||||
| originalc.co.uk | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| John & Nicole Santos Dairy | Center for Veterinary Medicine | New Animal Drug/Adulterated | |||||
| Lovelace Biomedical Research Institute | Center for Drug Evaluation and Research (CDER) | Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies | |||||
| Silgan Dispensing Systems | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | |||||
| Dreyer’s Grand Ice Cream, Inc. | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||||
| SCA Pharmaceuticals, LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |