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 16, 2012

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
October 11, 2012	Finca Cojobas, Inc.	San Juan District Office	PHS Act/Shell Egg Regulation/Adulterated	Not Issued *
October 10, 2012	PC Tan	Center for Devices and Radiological Health	Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)	Not Issued *
October 10, 2012	Zian Medical, LLC	Center for Devices and Radiological Health	Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)	Not Issued *
October 10, 2012	Nissei Precision Instruments (Suzhou) Co., Ltd	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated/Misbranded	Not Issued *
October 09, 2012	Stat Rx USA	Atlanta District Office	CGMP/Finished Pharmaceuticals/Adulterated/Misbranded	Not Issued *
October 09, 2012	Alere San Diego, Inc.	Los Angeles District Office	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
October 09, 2012	Medical Device Resource Corp	San Francisco District Office	Premarket Approval/Misbranded/Adulterated	Not Issued *
October 09, 2012	SMT-Schilling Metalltechnik GmbH	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated/Misbranded	Not Issued *
October 05, 2012	Avon Products, Inc. (U.S. Headquarters)	Center for Food Safety and Applied Nutrition	New Drug/Misbranded	Not Issued *
October 05, 2012	Bioque Technology	Center for Food Safety and Applied Nutrition	New Drug Application [NDA]	Not Issued *
October 05, 2012	Xiantao Rayxin Medical Products Co. Ltd.	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
October 04, 2012	Tropical Seafood	New Orleans District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	Not Issued *
October 02, 2012	AHN International Inc DBA Amazing Herbs Nutraceuticals	Atlanta District Office	CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated	Not Issued *
October 01, 2012	Bernick's Registered Holsteins	Minneapolis District Office	Illegal Drug Residue	Not Issued *
September 28, 2012	James G. Cole, Inc. dba Maxam Nutraceutics	Seattle District Office	CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated	Not Issued *
September 28, 2012	Pulse Health LLC	Seattle District Office	CGMP/QSR/Medical Devices/Adulterated/Misbranded	Not Issued *
September 27, 2012	Altura Food, Inc.	San Juan District Office	Juice HACCP/CGMP for Foods/Labeling/Misbranded	Not Issued *
September 27, 2012	Mid Pac Foods, Inc.	San Francisco District Office	Acidified Foods/CGMP Regulations/Adulterated	Not Issued *
September 26, 2012	Natures One Inc	Center for Food Safety and Applied Nutrition	Food Labeling/Misbranded	Not Issued *
September 26, 2012	Lime Essentials	Center for Devices and Radiological Health	Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)	Not Issued *
September 25, 2012	Copious International, Inc	Center for Devices and Radiological Health	Medical Device Reporting/Misbranded	Not Issued *
September 25, 2012	V and L Dairy	Seattle District Office	Illegal Drug Residue	Not Issued *
September 25, 2012	Acu International	Center for Devices and Radiological Health	Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)	Not Issued *
September 24, 2012	Celltex Therapeutics Corporation	Center for Biologics Evaluation and Research	Human Cells, Tissues & Cellular Products	Not Issued *
September 24, 2012	Texas Applied Biomedical Services	Center for Biologics Evaluation and Research	IRB (Institutional Review Board)	Not Issued *
September 12, 2012	DMC Medical Technology & Manufacturing Co., Ltd.	Center for Devices and Radiological Health	Quality System Regulation for Medical Devices/Adulterated	Not Issued *
September 11, 2012	EPS Biotechnology Corp.	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
September 11, 2012	Roberts Ranch of Oklahoma LLC	Dallas District Office	Illegal Drug Residue	Not Issued *
August 28, 2012	Creation's Garden Natural Products, Inc.	Los Angeles District Office	CGMP/Dietary Supplement/Adulterated/Misbranded	Not Issued *
April 10, 2012	Pleasant View Farms, Inc	Philadelphia District Office	Illegal Drug Residue	Not Issued *