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 |
|---|---|---|---|---|---|---|---|
| Boardwalk Elixir | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| The Juice Bar | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
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| InfuTronix LLC | Office of Medical Devices and Radiological Health Operations Div. 1 East | CGMP/QSR/Medical Devices/Adulterated | |||||
| Zyno Medical LLC | Office of Medical Devices and Radiological Health Operations Div. 1 East | CGMP/QSR/Medical Devices/Adulterated | |||||
| Vitti Labs, LLC | Office of Biological Products Operations – Division 2 | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | |||||
| Valley Biosystems | Center for Biologics Evaluation and Research (CBER) | Bioresearch Monitoring Program |
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| Muscle Feast, LLC | Office of Human and Animal Foods – East 5 | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated | |||||
| Amazon.com, Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug | |||||
| JB Exchange Inc./Justified Laboratories | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug |
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| Ariella Naturals | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug |