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 |
|---|---|---|---|---|---|---|---|
| Salon Technologies International, Inc. | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Mark S. Denker, M.D., PA dba Palm Beach Fertility Center | Division of Biological Products Operations I | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | |||||
| Quality Supplement Manufacturing, Inc. | Division of Pharmaceutical Quality Operations III | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated | |||||
| MicroVention Costa Rica S.R.L. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | |||||
| Getsch+Hiller Medizintechnik GmbH | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | |||||
| J.M. Smucker LLC | Division of Human and Animal Food Operations East V | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||||
| AMO and Wing Inc. dba T and H Trading Co. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | |||||
| HST Produce, Inc. | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | |||||
| The Body Bean, LLC | Center for Drug Evaluation and Research | CDER | Failure to Register and List | |||||
| Liquivape | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |