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 |
|---|---|---|---|---|---|---|---|
| Guangzhou Jiugong Research And Development Biotechnology Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Next Medical Products Company, LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | |||||
| La Cabana Food Distributing, Inc. | Human Foods Program | CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated | |||||
| Guangdong Bisutang Biotechnology Co., Ltd. | Center for Drug Evaluation and Research (CDER) | Refusal to Provide Access to and Copying of Records | |||||
| IF Co-Pack, LLC dba Initiative Foods | Human Foods Program | CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated | |||||
| whitedragonecigs.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| US Tov Inc. dba US Trading Company | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | |||||
| Safi Pushcart Supplies Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | |||||
| Guangdong Bangze Medicine Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| New Green Nutrition Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |