Warning Letters

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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

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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.

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  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.

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  Recently Posted Warning Letters

 

 

Posted on May 22, 2012

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
May 18, 2012	Process Managers LLC	Cincinnati District Office	New Animal Drug/Adulterated	Not Issued *
May 17, 2012	Capitol Foods, Inc.	Baltimore District Office	Seafood HACCP/Adulterated/Misbranded	Not Issued *
May 15, 2012	Smak Sp. z o.o.	Center for Food Safety and Applied Nutrition	Acidified Foods/Adulterated	Not Issued *
May 14, 2012	A&M De Sousa Dairy	San Francisco District Office	Illegal Drug Residue	Not Issued *
May 11, 2012	www.Low-Price-Cigarettes.com	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded	Not Issued *
May 11, 2012	Classica Trading Center	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded	Not Issued *
May 10, 2012	BTS S.p.A.	Center for Devices and Radiological Health	Device/Adulterated	Not Issued *
May 08, 2012	www.online-dutyfree.com	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded	Not Issued *
May 08, 2012	Reaction Nutrition, L.L.C.	Philadelphia District Office	CGMP for Dietary Supplements/Adulterated/Misbranded	Not Issued *
May 07, 2012	CareFusion Corp dba Productos Urologos De Mexico S.A. De C.V.	Center for Devices and Radiological Health	Device/Adulterated	Not Issued *
May 04, 2012	B.M.P. Pharma Trading AG	Center for Drug Evaluation and Research	CGMP/Finished Pharmaceuticals/Adulterated	Not Issued *
April 24, 2012	Tedec-Meiji Fanna, S.A.	Center for Drug Evaluation and Research	CGMP/Finished Pharmaceuticals/Adulterated	Not Issued *