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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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
October 27, 2011 Joe L. Pimentel Dairy [ARCHIVED] San Francisco District Office Illegal Drug Residue Not Issued *
October 26, 2011 Silveira Ranches [ARCHIVED] San Francisco District Office Illegal Drug Residue Not Issued *
October 26, 2011 B & F Fish Market Llc [ARCHIVED] New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
October 26, 2011 International Isotopes Inc. [ARCHIVED] Seattle District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
October 26, 2011 Laser Eye Care of California, LLC [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
October 26, 2011 Great American Marketing Company [ARCHIVED] Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
October 26, 2011 SterilMed, Inc. [ARCHIVED] Center for Devices and Radiological Health Adulterated Device/Misbranded May 22, 2012
October 25, 2011 Southwest Traders, Inc. [ARCHIVED] Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
October 25, 2011 Van Deurzen Dairy, LLC [ARCHIVED] Cincinnati District Office Illegal Drug Residue Not Issued *
October 25, 2011 Lester Troyer Farm [ARCHIVED] Cincinnati District Office Illegal Drug Residue Not Issued *
October 25, 2011 Onorato & Company, Inc. [ARCHIVED] San Francisco District Office CGMP for Foods/Seafood HACCP/Adulterated Not Issued *
October 24, 2011 Pastry Food Products, Inc. [ARCHIVED] San Juan District Office CGMP Manufacture, Processing, Packing or Holding Food/Adulterated/Misbranded Not Issued *
October 24, 2011 Procesadora El Cangrejito Del Mar C.A. (Procamar, C.A.) [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
October 24, 2011 Sea Fare Foods, Inc. [ARCHIVED] Detroit District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions January 10, 2013
October 21, 2011 Nurse Assist, Inc. [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/Adulterated August 17, 2012
October 21, 2011 Medical Compression Systems [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated August 16, 2012
October 21, 2011 Fremont Farms L.C. [ARCHIVED] Kansas City District Office PHS Act/Violation/Adulterated Not Issued *
October 21, 2011 Cagenix [ARCHIVED] New Orleans District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
October 21, 2011 Hanover Foods Corporation [ARCHIVED] Baltimore District Office CGMP Regulation For Food/Adulterated Not Issued *
October 20, 2011 Eiber Radiology, Inc. [ARCHIVED] Florida District Office Mammography Quality Standards November 10, 2011
October 20, 2011 Snokist Growers [ARCHIVED] Seattle District Office CGMP for Food, Prepared, Packaged or Held Under Insanitary Conditions/Adulterated Not Issued *
October 20, 2011 Bacalao Brothers, Inc. dba New England Fish Market [ARCHIVED] Florida District Office CGMP Regulation For Food/Adulterated Not Issued *
October 20, 2011 Beyer Lightning Fish Co. Inc. [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions April 17, 2012
October 19, 2011 Jenahexal Pharm GmbH [ARCHIVED] Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated & Unapproved New Drugs Not Issued *
October 19, 2011 Evergreen Fresh Sprouts, LLC [ARCHIVED] Seattle District Office Sprouts/Insanitary Conditions/Adulterated October 01, 2012
October 19, 2011 Simoes & Sons Dairy, Inc. [ARCHIVED] San Francisco District Office Illegal Drug Residue Not Issued *
October 18, 2011 Jensen Farms [ARCHIVED] Denver District Office Adulterated Food Not Issued *
October 18, 2011 Cracovia Co [ARCHIVED] New Jersey District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions August 27, 2013
October 17, 2011 Biomedica Diagnostics Inc [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 17, 2011 Health Advances USA, Inc. [ARCHIVED] Los Angeles District Office CGMP Regulations For Dietary Supplements/Adulterated Not Issued *
October 17, 2011 Old Point Packing, Inc [ARCHIVED] Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated May 31, 2012
October 17, 2011 Gro-Lan Farms [ARCHIVED] Philadelphia District Office Illegal Drug Residue November 21, 2013
October 17, 2011 New Life Generation, Inc. [ARCHIVED] Detroit District Office Human Cells, Tissues & Cellular Products Not Issued *
October 14, 2011 Teasley, Laura A., M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
October 13, 2011 Testing Center of Sanitation & Environment Technic Institute [ARCHIVED] Center for Devices and Radiological Health Adulterated Device/Misbranded January 31, 2014
October 13, 2011 Mylan LLC. [ARCHIVED] San Juan District Office CGMP for Finished Pharmaceuticals/Adulterated June 07, 2013
October 13, 2011 True World Foods Chicago LLC [ARCHIVED] Chicago District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions March 13, 2013
October 13, 2011 United Prosperity Group DBA The Produce Company [ARCHIVED] San Francisco District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions June 27, 2012
October 13, 2011 Rocket Medical Plc [ARCHIVED] Center for Devices and Radiological Health Adultered Device/Quality Control Not Issued *
October 13, 2011 Jansen’s Sweet Sinsations, Inc. [ARCHIVED] Cincinnati District Office CGMP Food/Adulterated/Misbranded May 30, 2012
October 12, 2011 Topcon Corporation [ARCHIVED] Center for Devices and Radiological Health Medical Devices/Adulterated/No PMA Not Issued *
October 12, 2011 Measurement Specialties, Inc. [ARCHIVED] Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 11, 2011 Respironics, Inc. [ARCHIVED] Philadelphia District Office Device/Adulterated April 12, 2012
October 11, 2011 Hong Kong Food Co. [ARCHIVED] Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
October 11, 2011 Bob Osborn [ARCHIVED] Detroit District Office Illegal Drug Residue October 01, 2012
October 11, 2011 Nordimex, LLC [ARCHIVED] Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
October 11, 2011 National Therapy Products, Inc. [ARCHIVED] Center for Devices and Radiological Health Medical Device/Misbranded/MDR Not Issued *
October 11, 2011 Jazz Pharmaceuticals, Inc [ARCHIVED] San Francisco District Office Postmarketing Adverse Drug Experience Reporting Requirements August 02, 2013
October 07, 2011 Sunshine Dairy [ARCHIVED] Detroit District Office Illegal Drug Residue February 15, 2012
October 07, 2011 SmithKline Beecham Limited [ARCHIVED] Center for Drug Evaluation and Research Finished Pharmaceuticals/Adulterated March 20, 2013

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