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 |
|---|---|---|---|---|---|---|---|
| IBSPOT.com Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
|||||
| Compass Group USA | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes | |||||
| Miers Laboratories, Ltd | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
|||||
| Taizhou Kangping Medical Science and Technology Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Artisan Vapor & CBD | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
|||||
| The Game Trader Inc | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
|||||
| Kure CBD & Vape | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Dermacare dba Filler Outlet | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded Botox | |||||
| Korean Aesthetic dba Korean Fillers | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded Botox | |||||
| Cosmenic | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded Botox |