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 |
|---|---|---|---|---|---|---|---|
| Sure-Biochem Laboratories, LLC | Division of Pharmaceutical Quality Operations I | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Champaklal Maganlal Homeo Pharmacy Private Limited | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | |||||
| Krishiv Foods, LLC | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) | |||||
| H.E.A.L. Marketplace | Division of Human and Animal Food Operations East III | New Drug/Misbranded | |||||
| Drive Thru Vapors, LLC d/b/a Drive Thru Vapors Dallas | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Sea-Long Medical Systems, LLC | Division of Medical Device and Radiological Health Operations West | CGMP/QSR/Medical Devices/Adulterated | |||||
| EarthLab, Inc., dba Wise Woman Herbals | Division of Human and Animal Food Operations West VI | Unapproved New Drugs/Misbranded | |||||
| Pharmedica USA, LLC | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Sorcerz.com | Center for Drug Evaluation and Research | CDER | Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet | |||||
| Gary’s Cheesecakes & Fine Desserts | Division of Human and Animal Food Operations East V | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |