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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 September 06, 2011

Letter Issue Date Company Name Issuing Office Subject Close Out Date
August 04, 2011 Creation's Garden Natural Products, Inc. Los Angeles District Office New Drug/Misbranded Not Issued *
August 04, 2011 Patient Transfer Systems, Inc Philadelphia District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated January 30, 2012
August 02, 2011 Deshaies' Associates, Inc., d/b/a Deshaies' Lobster Salad New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
August 02, 2011 Hoya Surgical Optics, Inc. Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
August 02, 2011 Sorin Group Deutschland GmbH Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
August 01, 2011 Hickory Smokehouse Miami, Inc. Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
August 01, 2011 Double M Jerseys San Francisco District Office Illegal Drug Residue Not Issued *
August 01, 2011 Pacific Cheese Company, Inc. San Francisco District Office Food/Adulterated August 20, 2012
August 01, 2011 Jin's Seafood Enterprise Inc., dba Choi's Fish Market San Francisco District Office Seafood HACCP/Adulterated Not Issued *
July 29, 2011 Pharmaceutical Innovations, Inc. New Jersey District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
July 29, 2011 www.online-smoke.com Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
July 28, 2011 HBB, LLC dba Baked World Center for Food Safety and Applied Nutrition Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded Not Issued *
July 28, 2011 Uttecht, Kenneth Minneapolis District Office Illegal Drug Residue October 12, 2011
July 28, 2011 Pine Groves Farm Ltd. Kansas City District Office Illegal Drug Residue November 07, 2012
July 28, 2011 Merex Inc Center for Food Safety and Applied Nutrition CGMP for Foods/Seafood HACCP/Adulterated Not Issued *
July 28, 2011 Timothy R. Nelson Kansas City District Office Illegal Drug Residue November 07, 2012
July 27, 2011 Gulf Medical Fiberoptics, Inc. Florida District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
July 27, 2011 La Villa Tortilleria, Inc. New Orleans District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated Not Issued *
July 27, 2011 Bionet Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
July 27, 2011 Diana Fruit Company Incorporated San Francisco District Office Acidified Foods/Acid Canned Food Regulation/Adulterated October 11, 2012


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