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 October 02, 2012

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
September 21, 2012	Janson-Beckett	Center for Food Safety and Applied Nutrition	New Drug Application [NDA]	Not Issued *
September 21, 2012	Andes Natural	Center for Food Safety and Applied Nutrition	New Drug Application [NDA]	Not Issued *
September 18, 2012	Grindstone Neck of Maine, LLC	New England District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	Not Issued *
September 18, 2012	Eyal Bar Oz	Center for Drug Evaluation and Research	Unapproved and Misbranded New Drugs	Not Issued *
September 14, 2012	EMG Manufacturing Co., Ltd.	Center for Devices and Radiological Health	CGMP/QSR/Medical Device Reporting/Adulterated/Misbranded	Not Issued *
September 14, 2012	Oregon Aesthetic Technologies, Inc.	Seattle District Office	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
September 12, 2012	C.C. & Son Farms, Incorporated	San Francisco District Office	PHS Act/Violation/Adulterated	Not Issued *
September 06, 2012	Quzhou Chemsyn Pharm Co Ltd	Center for Drug Evaluation and Research	Failure to Register and List	Not Issued *
September 05, 2012	Petaluma Farms	San Francisco District Office	PHS Act/Shell Egg Regulation/Adulterated	Not Issued *
August 27, 2012	Cendano Corporation Ltd.	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded	Not Issued *
August 22, 2012	Cape Florida Seafood, Inc.	Florida District Office	Seafood HACCP/Adulterated	Not Issued *
July 10, 2012	The American Bottling Company, Inc.	Dallas District Office	Juice HACCP/Adulterated	Not Issued *
April 06, 2012	Upspring, Ltd	Center for Devices and Radiological Health	Medical Device/Adulterated/Misbranded	Not Issued *
December 19, 2011	Satyaprakash N. Makam, MD	Center for Devices and Radiological Health	Investigational Review Board (IRB)/Medical Devices	Not Issued *