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.
| Posted Date | Letter Issue Date | Company Name | Issuing Office | Subject | Response Letter | Closeout Letter | Excerpt |
|---|---|---|---|---|---|---|---|
| HiggyCigs LLC d/b/a Viral Vapes | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| HiggyCigs, LLC d/b/a Viral Vapes | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| HiggyCigs, LLC d/b/a Viral Vapes | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Intas Pharmaceuticals Limited | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Shenzhen IJOY Technology Co., LTD. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Dr. Berne’s Whole Health Products | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug |
|||||
| Shenzhen FreeMax Technology Co., Ltd. d/b/a FreeMaxVape | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Melanie M. Hoppers, M.D./Physicians Quality Care | Center for Drug Evaluation and Research | CDER | Clinical Investigator | |||||
| Discover Health, LLC d/b/a Discover CBD and Strain Snobs | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drugs/Animal Drugs/Human Foods/Animal Foods/Adulterated/Misbranded | |||||
| Cipla Limited | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |