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 September 11, 2012

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
September 07, 2012	Lancome	Center for Food Safety and Applied Nutrition	New Drug Application [NDA]	Not Issued *
September 07, 2012	Greek Island Labs	Center for Food Safety and Applied Nutrition	New Drug Application [NDA]	Not Issued *
September 05, 2012	Trans-Pacific Assets Management Inc.	San Francisco District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	Not Issued *
September 05, 2012	Yangpo Foods Co.,Ltd.	Center for Food Safety and Applied Nutrition	Seafood HACCP/Adulterated	Not Issued *
September 05, 2012	MDK Enterprises, Inc dba Maui Jelly Factory	San Francisco District Office	Acidified Foods/Adulterated	Not Issued *
August 30, 2012	Fresh Mushroom Farm Inc	Kansas City District Office	CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions	Not Issued *
August 28, 2012	Regeneca, Inc	Los Angeles District Office	Dietary Supplement/Adulterated	Not Issued *
August 28, 2012	Trinity Sports Group, Inc.	Dallas District Office	New Drug/Labeling/Misbranded	Not Issued *
August 28, 2012	Wendell Corporation dba Regalo Bakery	San Francisco District Office	CGMP Regulation for Foods/Adulterated	Not Issued *
August 27, 2012	PruTect Rx	Denver District Office	New Drug/Labeling/Misbranded	Not Issued *
August 23, 2012	bioMerieux, Inc.	Atlanta District Office	CGMP/QSR/Medical Devices/Adulterated/Misbranded	Not Issued *
August 22, 2012	Global Biotechnologies, Inc.	New England District Office	CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated	Not Issued *
August 22, 2012	CoffeeCigarette.com	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded	Not Issued *
August 16, 2012	TCM Supply Corporation	Los Angeles District Office	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
August 15, 2012	Generic Medical Devices, Inc.	Seattle District Office	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
August 08, 2012	Kimberly-Clark Corporation	Atlanta District Office	Devices/Misbranded	Not Issued *
August 02, 2012	Henrys Farm Inc.	Baltimore District Office	Insanitary Conditions/Adulterated	Not Issued *
August 01, 2012	Chu Minh Corp dba Chu Minh Tofu	Seattle District Office	CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions	Not Issued *
June 28, 2012	Apia Enterprise Inc	Los Angeles District Office	Medical Device Reporting/Misbranded	Not Issued *