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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
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 *
February 10, 2011 Tabatchnick Fine Foods, Inc. New Jersey District Office Labeling/False & Misleading Claims/Misbranded Not Issued *
February 10, 2011 International Fish Canners (Scotland) Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP April 08, 2011
February 10, 2011 Global Protein Foods, Inc. New Jersey District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
February 09, 2011 Abba Pharma Inc. Florida District Office Dietary Supplement/Adulterated Not Issued *
February 09, 2011 Ancient Formulas Inc. Kansas City District Office Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded Not Issued *
February 09, 2011 Dean Blanchard Seafood, Inc. New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
February 09, 2011 Vita Pure Inc New Jersey District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
February 09, 2011 Nachman's Native Seafood Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
February 09, 2011 Sanofi Aventis Deutschland GmbH Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Misbranded/Adulterated August 14, 2012
February 09, 2011 Bioptigen Inc Center for Devices and Radiological Health Devices/Misbranded Not Issued *
February 09, 2011 Steris Corporation Center for Devices and Radiological Health Devices/Misbranded Not Issued *
February 08, 2011 Toxin Technology, Inc. Florida District Office CGMP/Adulterated April 26, 2012
February 08, 2011 Hawkeye Jensen Inc Philadelphia District Office CGMP for Finished Pharmaceuticals/Misbranded/Adulterated December 20, 2011
February 07, 2011 Snow White Food Products, Inc. New York District Office Insanitary Conditions/Adulterated Not Issued *
February 07, 2011 Southern Implants, (Pty.) Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated October 09, 2012



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