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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 October 04, 2011

Letter Issue Date Company Name Issuing Office Subject Close Out Date
September 12, 2011 Hildebrandt Farms Chicago District Office Illegal Drug Residue Not Issued *
September 12, 2011 Productos Marinos,C.A (Promarca) Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
September 12, 2011 The Cherry Co., Ltd. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
September 12, 2011 P.T. Intimas Surya Center for Food Safety and Applied Nutrition Seafood HACCP Not Issued *
September 09, 2011 United Contact Lens Seattle District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated February 22, 2012
September 09, 2011 Dr Foster'S Essentials Los Angeles District Office Labeling/False & Misleading Claims/Misbranded Not Issued *
September 09, 2011 Zoka Coffee Company, LLC Seattle District Office Current Good Manufacturing Practice Requirements for Foods/Adulterated May 03, 2012
September 09, 2011 Nutri-West, Incorporated Denver District Office CGMP For Manufacturing, Packaging, Labeling, or Holding for Dietary Supplements/Adulterated January 24, 2013
September 09, 2011 Sichuan Pharmaceutical Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
September 08, 2011 RX Air Industries LLC. Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
September 08, 2011 Postres de Aqui, Inc. San Juan District Office Food Labeling/Adulterated/Misbranded Not Issued *
September 08, 2011 Paramount Muffins, LLC New Jersey District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions August 29, 2012
September 07, 2011 Chronicity Inc. Dallas District Office Labeling/False & Misleading Claims/New Drug/Misbranded Not Issued *
September 07, 2011 Covenant Healthcare Center for Drug Evaluation and Research IRB (Institutional Review Board) Not Issued *
September 06, 2011 24/7 Seafood Distributor Corp. Florida District Office CGMP Regulation For Food/Adulterated Not Issued *
September 06, 2011 High Quality Organics, Inc. San Francisco District Office Interstate Commerce/Food/Adulterated June 27, 2012
September 06, 2011 Advantage Foods, LLC Florida District Office CGMP Regulation For Food/Adulterated Not Issued *
September 01, 2011 Lonza Biologics, Inc. New England District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
September 01, 2011 Deibel Laboratories of Illinois, Inc. Chicago District Office Current Good Manufacturing Practice for Finished Pharmaceuticals/Misbranded/Adulterated Not Issued *
August 31, 2011 Luitpold Pharmaceuticals, Inc. New York District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *


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