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 |
|---|---|---|---|---|---|---|---|
| Accra-Pac, Inc. dba Voyant Beauty | Division of Pharmaceutical Quality Operations III | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Spartan Enterprises Inc. dba Watershed Wellness Center | Division of Human and Animal Food Operations East VI | Unapproved New Drugs/Misbranded | |||||
| Pop Daddy Popcorn, LLC | Division of Human and Animal Food Operations East VI | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||||
| Pharmaplast S.A.E. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Five Star Trading IL, Inc. | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Medivance Instruments Ltd. | Center for Devices and Radiological Health | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) |
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| Nose Slap LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | |||||
| Medolife Rx D/B/A MedoLife Corp., AELIA, Inc. and Quanta Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | |||||
| FuZion Vapor LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Abbott Point of Care Canada Limited | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |