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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
August 05, 2011 Superstat Corp Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
August 05, 2011 Nanjing Maohai Biotech Co. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
August 05, 2011 Zhejiang Casing Animal By-Products Co. Ltd Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
August 05, 2011 Lisbon Centre Farms New York District Office Illegal Drug Residue Not Issued *
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 Sorin Group Deutschland GmbH Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
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 01, 2011 Pacific Cheese Company, Inc. San Francisco District Office Food/Adulterated August 20, 2012
August 01, 2011 Double M Jerseys San Francisco District Office Illegal Drug Residue 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 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 Merex Inc Center for Food Safety and Applied Nutrition CGMP for Foods/Seafood HACCP/Adulterated Not Issued *
July 28, 2011 Pine Groves Farm Ltd. Kansas City District Office Illegal Drug Residue November 07, 2012
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 Timothy R. Nelson Kansas City District Office Illegal Drug Residue November 07, 2012
July 28, 2011 Uttecht, Kenneth Minneapolis District Office Illegal Drug Residue October 12, 2011



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