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 |
|---|---|---|---|---|---|---|---|
| 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 | |||||
| Ong Tien USA LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | |||||
| Bella’s Nutri Shop Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | |||||
| Jing Cheong Asia Inc. dba New York Tong Ren Tang | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | |||||
| Phuoc Loc Tho Herbals, Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
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| Natuzem | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | |||||
| 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 |