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 |
---|---|---|---|---|---|---|---|
Grimann S.A. de C.V. | Center for Drug Evaluation and Research | CDER | Failure to Comply with Drug Registration and Listing Requirements | |||||
Yippee Farms, LLC | Division of Human and Animal Food Operations East II | Illegal Drug Residue Animal Tissue/Adulterated | |||||
OsteoLife Biomedical I LLC | Office of Biological Products Operations – Division I | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | |||||
New Vitalis, LLC dba New Vitalis Pharmacy | Division of Pharmaceutical Quality Operations III | Compounding Pharmacy/Adulterated Drug Products |
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CAJ Food Products Inc. | Office of Human and Animal Food Operations East Division 6 | New Drug/Misbranded | |||||
Russ Davis Wholesale Inc | Office of Human and Animal Food Operations - West Division 1 | Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | |||||
Freeman and Biddy, LLC d/b/a Freedom Vapes | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Wick ‘N’ Vape, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Hope Botanicals, LLC | Center for Veterinary Medicine | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
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Plantacea, LLC dba Kahm | Center for Veterinary Medicine | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |