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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
October 31, 2011 AD and AD International, Ltd. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
October 31, 2011 Pt. Bitung Mina Utama Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
October 31, 2011 Global Bakery Corporation San Juan District Office Food Labeling July 12, 2012
October 31, 2011 IndoCigs Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
October 28, 2011 Alabama Sunshine, Inc. New Orleans District Office CGMP/Acidified Foods/Adulterated August 04, 2014
October 28, 2011 Wrapers Kitchen Denver District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
October 28, 2011 Hayai Zushi Denver District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
October 27, 2011 Joe L. Pimentel Dairy San Francisco District Office Illegal Drug Residue/Adulterated Not Issued *
October 27, 2011 Seven Seas Seafoods Inc. Los Angeles District Office Seafood HACCP/Adulterated Not Issued *
October 26, 2011 B & F Fish Market Llc New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
October 26, 2011 International Isotopes Inc. Seattle District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
October 26, 2011 Silveira Ranches San Francisco District Office New Animal Drug/Adulterated Not Issued *
October 26, 2011 Laser Eye Care of California, LLC Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
October 26, 2011 Great American Marketing Company Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
October 26, 2011 SterilMed, Inc. Center for Devices and Radiological Health Adulterated Device/Misbranding May 22, 2012
October 25, 2011 Lester Troyer Farm Cincinnati District Office Illegal Drug Residue Not Issued *
October 25, 2011 Onorato & Company, Inc. San Francisco District Office CGMP for Foods/Seafood HACCP/Adulterated Not Issued *
October 25, 2011 Van Deurzen Dairy, LLC Cincinnati District Office Illegal Drug Residue/Adulterated Not Issued *
October 25, 2011 Southwest Traders, Inc. Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
October 24, 2011 Procesadora El Cangrejito Del Mar C.A. (Procamar, C.A.) Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *



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