Inspections, Compliance, Enforcement, and Criminal Investigations

Warning Letters

Recently Posted | 2019 | 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
03/18/2019 Sientra Inc Center for Devices and Radiological Health Premarket Approval/Adulterated Not Issued *
03/18/2019 Mentor Worldwide LLC & Acclarent Center for Devices and Radiological Health Premarket Approval/Adulterated Not Issued *
03/11/2019 Merchants Market St. Croix LLC San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
03/11/2019 Nutra Pharma Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded Not Issued *
03/07/2019 Flea Assassin, LLC Dallas District Office New Animal Drug/Adulterated Not Issued *
03/06/2019 United Exchange Corporation Los Angeles District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
03/06/2019 TEI Biosciences, Inc. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
03/06/2019 Cosmos Indian Store Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
03/05/2019 Hanna's Herb Shop Denver District Office New Drug/Misbranded Not Issued *
03/04/2019 Alpha Feed Mill, Inc Chicago District Office CGMP/Medicated Feeds/Adulterated Not Issued *
02/05/2019 LaMarquise Inc. Cincinnati District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   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: 03/19/2019
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