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 |
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ALI Pharmaceutical Manufacturing, LLC | Division of Pharmaceutical Quality Operations III | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | |||||
Samm Solutions, Inc., d.b.a. BTS Research | Center for Drug Evaluation and Research | CDER | Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies |
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WAVi Co. | Division of Medical Device and Radiological Health Operations West | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | |||||
Maria W. Greenwald, M.D. | Center for Drug Evaluation and Research | CDER | Clinical Investigator | |||||
Cajun Vapes LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Trippy Drips LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
FF Vapors, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Abbott Laboratories | Center for Biologics Evaluation and Research (CBER) | Dietary Supplement/Adulterated |
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Suther Feeds, Inc. | Division of Human and Animal Food Operations West II | CGMP/Medicated Feeds/Adulterated | |||||
Golden Natural Products | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |