Warning Letters

Recently Posted | 2012 | 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996 |

Tobacco Retailer Warning Letters

 

Types of Warning Letters on the FDA Website

• General FDA Warning Letters
• Tobacco Retailer Warning Letters
• Drug Marketing and Advertising Warning Letters (and Untitled Letters to Pharmaceutical Companies)

Read more about types of warning letters

Topics on this Page: 

• Ways to View/Browse Warning Letters
• More Information About Warning Letters Posted Here
• Recently Posted Warning Letters

---

Sign Up to Receive Warning Letter Updates

---

Ways to View/Browse Warning Letters

To view Warning Letters by date:

• Review the list of recently posted warning letters below.

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.

To find specific Warning Letters:

• Perform a simple search by entering criteria into the search box below.

 

 

• Or:

  • Perform an Advanced Search
  • Use any of these "Browse" functions:
    • Browse Warning Letters by Company
    • Browse Warning Letters by Issuing Office
    • Browse Warning Letters by Subject
    • Browse Warning Letters with Response Letters
    • Browse Warning Letters with Closeout Letters

  To download information about Warning Letters to an Excel document:

  • Use the Search and Export Warning Letters to Excel function.

  ---

  More Information about Warning Letters Posted Here

  • Warning letters posted before June 25, 2001, are in PDF format. Warning letters posted after that date are available in HTML format.
  • Persons with disabilities having problems accessing PDF files may call 301-827-6567 for assistance.
  • 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 available additional information on the current status of an issue in a particular warning letter on this site, contact FDA. Requests to FDA for agency records should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5600 Fishers Lane, Rockville, MD 20857. Instructions for how to submit an FOI request can be found at How to Make a FOIA Request.

  ---

  Recently Posted Warning Letters

 

 

Posted on May 15, 2012

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
May 11, 2012	Lym-R-Flo Farm	New York District Office	Illegal Drug Residue	Not Issued *
May 10, 2012	Acorda Therapeutics Inc.	New York District Office	Adverse Drug Experience (ADE)	Not Issued *
May 08, 2012	Reaction Nutrition, L.L.C.	Philadelphia District Office	CGMP for Dietary Supplements/Adulterated/Misbranded	Not Issued *
May 08, 2012	American Yeast Corp. Tennessee	New Orleans District Office	CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions	Not Issued *
May 07, 2012	Quadex Pharmaceuticals, LLC	Denver District Office	OTC Drug Labeling/New Drug/Misbranded	Not Issued *
May 07, 2012	info@discount-cigarettes-online.biz	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded	Not Issued *
May 03, 2012	Inova Health Care Services, Inova Blood Donor Services	Baltimore District Office	CGMP Regulation for Blood and Blood Products/Adulterated	Not Issued *
May 02, 2012	Amplivox Ltd	Center for Devices and Radiological Health	CGMP for Medical Devices/QSR/Adulterated	Not Issued *
May 02, 2012	Andersen Sterilizers Inc	Atlanta District Office	Premarket Approval/Misbranded	Not Issued *
May 01, 2012	JC's Fish & BBQ Inc.	Dallas District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	Not Issued *
April 27, 2012	AJ Cigarettes	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded	Not Issued *
April 27, 2012	Selder S.A. de C.V.	Center for Drug Evaluation and Research	CGMP/Finished Pharmaceuticals/Misbranded	Not Issued *
April 26, 2012	Scariano Brothers, LLC	New Orleans District Office	Seafood HACCP/CGMP for Foods/Adulterated	Not Issued *
January 10, 2012	Progressive Medical Inc	Kansas City District Office	CGMP/QSR/Medical Devices/Adulterated/Misbranded	Not Issued *
December 28, 2011	Vaughan Foods Inc. (Allison's Gourmet Kitchen)	Dallas District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	Not Issued *