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Inspections, Compliance, Enforcement, and Criminal Investigations

Warning Letters

Recently Posted Warning Letters

 

To view Warning Letters by date, use the left-hand navigation column to select a year in which a Warning Letter was issued. You may further refine your search by using our "Browse By..." functions below. To search for Warning Letters and download information about those Warning Letters to an Excel document, you can use the Search and Export Warning Letters to Excel function. To do perform a simple search enter your criteria into the search box below.

 

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All Warning Letters posted prior to June 25th, 2001 are in PDF format. Warning Letters posted after June 25, 2001 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 recipient of the letter that may have changed the regulatory status of the issues discussed in the letter. If you wish to obtain available additional information on the current status of an issue in a particular Warning Letter on this Web site, please contact the Agency. 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 on our Web site:  How to Make a FOIA Request.

Letter Issue Date Company Name Issuing Office Subject
June 26, 2009 Gordon, Mark, M.D. Center for Drug Evaluation and Research Clinical Investigator
June 25, 2009 Chesterfield Dairy Cincinnati District Office Animal Sale for Slaughter as Food/Adulterated
June 16, 2009 Zosa, Noli R., M.D. Center for Drug Evaluation and Research Clinical Investigator
June 15, 2009 Dennis Paper and Food Service New England District Office Seafood HACCP/CGMP for Foods/Adulterated
June 10, 2009 Inditherm Medical Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated
June 05, 2009 The South Bend Chocolate Company, Inc. Detroit District Office CGMP For Manufacturing, Packing, Storage or Installation/Adulterated/Misbranded
April 10, 2009 Puretone Ltd. Center for Devices and Radiological Health CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation
March 02, 2009 Cote, Charles J., MD Center for Drug Evaluation and Research Clinical Investigator
December 30, 2008 Dongkuk Techco Rubber Ind. Sdn Bhd Center for Devices and Radiological Health CGMP/QSR/Adulterated
October 02, 2008 Madespa S.A. Center for Devices and Radiological Health CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated
August 21, 2008 Brede, Inc. Detroit District Office CGMP/Deviations For Food Manufacturers/Adulterated
August 08, 2008 Allez Spine, LLC Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated
May 16, 2008 Western United Fish Company, Inc. Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated
February 12, 2008 Michael S. Miller, D.O. Center for Biologics Evaluation and Research Investigational Device Exemptions (Clinical Investigator)
January 07, 2008 Reed's Compounding Pharmacy Los Angeles District Office New Drug/False Misleading/Labeling/Misbranded
January 07, 2008 Pacifica Pharmacy Los Angeles District Office New Drug/False Misleading/Labeling/Misbranded
January 07, 2008 Village Compounding Pharmacy Dallas District Office New Drug/False Misleading/Labeling/Misbranded
November 01, 2007 Troy Innovative Instruments, Inc. Cincinnati District Office CGMP for Medical Devices/QS/Adulterated
October 30, 2007 Chung's Products, LP Dallas District Office Seafood HACCP/Adulterated
September 11, 2007 Tembec, Inc. Cincinnati District Office Food Additive/Adulterated/Misbranded
August 28, 2007 Leiner Health Products, LLC Atlanta District Office CGMP for Finished Pharmaceuticals/Deviations/Adulterated
August 21, 2007 Beef Northwest Feeders, LLC Seattle District Office Animals for Sale for Slaughter as Food/Adulterated
August 17, 2007 Hain Celestial Group, Inc. Center for Food Safety and Applied Nutrition Dietary Supplement/Adulterated
June 26, 2007 Preferred Freezer Services, Inc. New Jersey District Office Seafood HACCP/Adulterated
March 02, 2007 North American Medical Corporation Atlanta District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded
February 01, 2007 Patient Advocacy Council, Inc. Center for Biologics Evaluation and Research Institutional Review Board
January 09, 2007 Advanced Reproductive Laboratory Dallas District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products
November 27, 2006 Health Dimensions, Inc. Detroit District Office Pharmacy Compounding/New Drug/Misbranded
December 19, 2005 Tidman, Raymond E., M.D. Center for Drug Evaluation and Research Clinical Investigator
November 21, 2005 Revival Animal Health, Inc. Kansas City District Office Promotional Claims False & Misleading/Adulterated/Misbranded
March 07, 2005 Rapid Recovery Health Services Inc. Center for Devices and Radiological Health Lacks Premarket Approval/Adulterated/Misbranded
May 03, 2004 Peak Performance Foods, LLC Cincinnati District Office Food Labeling/Misbranded
April 05, 2004 Electro Therapeutic Devices, Inc. Center for Devices and Radiological Health QSR for Medical Devices/Medical Device Reporting/Misbranded/Adulterated
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