Inspections, Compliance, Enforcement, and Criminal Investigations

Warning Letters

Recently Posted | 2018 | 2017 | 2016 | 2015 | 2014 | 2013

Archived Warning Letters: 2012 | 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005

Tobacco Retailer Warning Letters

 

Types of Warning Letters on the FDA Website

Read more about types of warning letters

Topics on this Page: 


Email Icon for GovDeliverySign Up to Receive Warning Letter Updates


Ways to View/Browse Warning Letters

To view Warning Letters by date:

Or:

  • Select the year from the list above in which the warning letter was issued, and browse the chronological list of warning letters on the linked page.

 

Letter Issue Date Company Name Issuing Office Subject Close Out Date
05/18/2018 Sunergized LLC Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *
05/18/2018 Kratom Spot Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
05/18/2018 Revibe, Inc. Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
05/18/2018 Napa Valley Bioscience Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *
05/18/2018 GliSODin Skin Nutrients Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *
05/18/2018 Pharmacy Direct, PDU Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *
05/18/2018 CV7 Holdings LLC Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *
05/18/2018 Front Range Kratom Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
05/16/2018 New England Confectionery Company, Inc. Center for Food Safety and Applied Nutrition CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
05/15/2018 Cerno Pharmaceutical Dallas District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
05/09/2018 Nox Bellcow Cosmetics Co. Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
05/09/2018 Montana Compounding Pharmacy PC Los Angeles District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
05/07/2018 Emmett F. Branigan, MD, PS, Inc Los Angeles District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Not Issued *

Contact FDA

ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857

Page Last Updated: 05/24/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English