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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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2011 Warning Letters

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Warning Letters issued in 2011

 

* Not issued: A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.

* N/A: Not applicable, the Warning Letter was issued prior to September 1, 2009.

Read more about warning and close-out letters

Posted on March 22, 2011

Letter Issue Date Company Name Issuing Office Subject Close Out Date
February 18, 2011 Tytan Medical, Corp. Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
February 18, 2011 Nutrasilver.com San Francisco District Office New Drug/Labeling/Misbranded Not Issued *
February 17, 2011 Truman Sanner, DVM Atlanta District Office Animal Drug/Adulterated Not Issued *
February 17, 2011 Millennium Bioceutics Center for Food Safety and Applied Nutrition New Drugs/Dietary Supplements/Food Labeling/Misbranded Not Issued *
February 17, 2011 Rasi Laboratories, Inc. New Jersey District Office CGMP/Dietary Supplement/Adulterated August 16, 2011
February 17, 2011 Conservas y Congelados YAESTA, S.A. Center for Food Safety and Applied Nutrition Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
February 17, 2011 Mancha, Vaughn H Jr, M. D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
February 16, 2011 Dobake Bakeries, Inc. San Francisco District Office Foods/Misbranding Not Issued *
February 16, 2011 Mave Enterprises, Inc. Los Angeles District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions August 09, 2011
February 16, 2011 Ratzan, Judith M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
February 16, 2011 RHG & Company Inc., dba Vital Nutrients New England District Office Dietary Supplement/Adulterated February 13, 2012
February 16, 2011 Cordis LLC San Juan District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated December 15, 2011
February 16, 2011 Leong Kuba Sea Products, Inc Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions September 27, 2011
February 15, 2011 Jesse R. Petre Farm Philadelphia District Office Animals for Sale for Slaughter as Food/Adulterated Not Issued *
February 15, 2011 Lloyd B. Zimmerman and Sons Philadelphia District Office Animals for Sale for Slaughter as Food/Adulterated Not Issued *
February 14, 2011 Tyco Healthcare Canada Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
February 14, 2011 Two Amigos Import & Export Inc Florida District Office PHS Act/Violation May 31, 2012
February 14, 2011 A-1 Eastern Homade Pickle Co., Inc. Los Angeles District Office CGMP Regulation for Foods/Adulterated Not Issued *
February 11, 2011 Anulex Technologies, Inc. Center for Devices and Radiological Health Investigational Device Exemptions Not Issued *
February 10, 2011 Formatech Inc. New England District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *


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