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  1. Compliance Actions and Activities

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
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
Ariella Naturals Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug
Valley Biosystems Center for Biologics Evaluation and Research (CBER) Bioresearch Monitoring Program
Vitti Labs, LLC Office of Biological Products Operations – Division 2 Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Zyno Medical LLC Office of Medical Devices and Radiological Health Operations Div. 1 East CGMP/QSR/Medical Devices/Adulterated
InfuTronix LLC Office of Medical Devices and Radiological Health Operations Div. 1 East CGMP/QSR/Medical Devices/Adulterated

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