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 |
|---|---|---|---|---|---|---|---|
| The Platinum Healthcare LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs | |||||
| Unilam Co., LTD | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | |||||
| Tipical Latin Food, Corp. DBA La Pradera | Human Foods Program | CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions | |||||
| Walmart, Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs |
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| Aidance Scientific, Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs | |||||
| Graceful Touch, LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs | |||||
| Pine Pharmaceuticals, LLC | Center for Drug Evaluation and Research (CDER) | Compounding Pharmacy/Adulterated Drug Products | |||||
| TCI Co., Ltd BioCosme PABP BRANCH | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| O.N. Diagnostics, LLC | Center for Devices and Radiological Health | Medical Device Reporting/Misbranded | |||||
| Online Generic Medicine/www.onlinegenericmedicine.com | Center for Drug Evaluation and Research (CDER) | Unapproved New Drug/Misbranded (Internet Pharmacy) |