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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

Recently Posted | 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996

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
10/06/2011 Eastern Treats Specialty Foods, Inc. [ARCHIVED] Florida District Office CGMP Regulation For Food/Adulterated 04/16/2012
10/05/2011 Dante Confections [ARCHIVED] New England District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated/Misbranded 11/01/2012
10/05/2011 Island Desserts LLC [ARCHIVED] New England District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 07/13/2012
10/04/2011 Akers Biosciences, Inc. [ARCHIVED] New Jersey District Office Premarket Approval/Adulterated 09/27/2012
10/04/2011 Oridion Medical 1987 Ltd. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
10/04/2011 Advantageous Md Llc [ARCHIVED] Baltimore District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
09/30/2011 GRAND BK CORP. [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated 03/23/2012
09/30/2011 El Chilerito Spice Co. Inc. [ARCHIVED] Los Angeles District Office Food/Labeling/Misbranded Not Issued *
09/30/2011 Vitalie Rotaru [ARCHIVED] Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/30/2011 Repostería Aymat, Inc. [ARCHIVED] San Juan District Office CGMP For Manufacturing, Packing,or Holding Food/Adulterated/Misbranded 09/27/2013
09/29/2011 Villa Tatra, Inc. [ARCHIVED] Denver District Office Seafood HACCP/CGMP for Foods/Adulterated 09/10/2012
09/29/2011 DJ Tuna Express Inc. [ARCHIVED] Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
09/29/2011 Donuts Deluxe [ARCHIVED] Minneapolis District Office Food Labeling Misbranded 04/20/2012
09/28/2011 Lebanese Arak Corp [ARCHIVED] Los Angeles District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
09/27/2011 Cantor & Nissel Ltd. [ARCHIVED] Center for Devices and Radiological Health Adulterated Device/Misbranding/Quality Control Not Issued *
09/27/2011 Middlesboro Appalachian Regional Hospital [ARCHIVED] Cincinnati District Office Mammography Quality Standards Act Not Issued *
09/26/2011 Aesculap AG [ARCHIVED] Center for Devices and Radiological Health Adulterated Device/Misbranded 11/13/2013
09/23/2011 K. Heeps, Inc [ARCHIVED] Philadelphia District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 03/13/2012
09/23/2011 X-Ray Support, Inc. [ARCHIVED] Seattle District Office CGMP For Manufacturing, Packing, Storage or Installation/Adulterated Not Issued *
09/22/2011 Florida Fruit Juices, Inc. [ARCHIVED] Chicago District Office Food Labeling/Misbranded 09/10/2012
09/22/2011 Herbal Nitro Inc. [ARCHIVED] Los Angeles District Office CGMP For Manufacturing, Packaging, Labeling, or Holding for Dietary Supplements/Adulterated 04/03/2013
09/21/2011 SPHERE Inc. [ARCHIVED] Center for Drug Evaluation and Research Unapproved and Misbranded New Drugs Not Issued *
09/21/2011 Chippewa Valley Veterinary Clinic, Ltd. [ARCHIVED] Minneapolis District Office Illegal Drug Residue 02/03/2012
09/21/2011 ECRS, LLC dba Big Chef [ARCHIVED] Florida District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
09/21/2011 Galyna / Ivan Podornikova [ARCHIVED] Center for Drug Evaluation and Research Unapproved and Misbranded New Drugs Not Issued *
09/21/2011 OraWell USA [ARCHIVED] Philadelphia District Office Device/Adulterated/Misbranded 03/14/2012
09/20/2011 Heartland Products, Inc [ARCHIVED] Kansas City District Office CGMP Regulation For Food/Adulterated Not Issued *
09/20/2011 Magic Mousse, Inc. dba Buttercream [ARCHIVED] Minneapolis District Office Food Labeling Misbranded 04/20/2012
09/20/2011 Columbia University Medical Center RDRC [ARCHIVED] Center for Drug Evaluation and Research Radioactive Drug Research Committee (RDRC) Not Issued *
09/20/2011 Botanic Oil Innovations, Inc. [ARCHIVED] Minneapolis District Office CGMP Regulations For Dietary Supplements/Adulterated 06/22/2015
09/19/2011 Nature's Rite [ARCHIVED] Denver District Office Dietary Supplement/Labeling/False & Misleading Claims/Misbranded Not Issued *
09/16/2011 Farriss Dairy Farms [ARCHIVED] Cincinnati District Office Illegal Drug Residue Not Issued *
09/16/2011 Capitol Food Services d.b.a Double A Provisions LLC [ARCHIVED] New York District Office Seafood HACCP/Adulterated Not Issued *
09/16/2011 TCHO Ventures, Inc. [ARCHIVED] San Francisco District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
09/16/2011 Euphoria Fancy Food Inc [ARCHIVED] New York District Office Seafood HACCP/Adulterated Not Issued *
09/16/2011 Algonot, LLC [ARCHIVED] Florida District Office New Drug/Misbranded Not Issued *
09/15/2011 Dental Technologies, Inc. [ARCHIVED] Chicago District Office CGMP for Finished Pharmaceuticals/Adulterated 05/29/2012
09/15/2011 Rausch Farms [ARCHIVED] Minneapolis District Office Illegal Drug Residue 11/22/2011
09/15/2011 Bednarek Brothers [ARCHIVED] Minneapolis District Office Illegal Drug Residue 11/22/2011
09/14/2011 Hensley, Jimmy A. [ARCHIVED] San Francisco District Office Illegal Drug Residue Not Issued *
09/14/2011 P.T. Bonecom aka Bone Commercial Company [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
09/14/2011 International Immuno-Diagnostics [ARCHIVED] San Francisco District Office Premarket Approval/Adulterated Not Issued *
09/14/2011 Gilman Cheese Corporation [ARCHIVED] Minneapolis District Office Low Acid Canned Food Regulation/Adulterated 06/26/2012
09/12/2011 Aramark Healthcare Albany Production Center [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
09/12/2011 Hildebrandt Farms [ARCHIVED] Chicago District Office Illegal Drug Residue Not Issued *
09/12/2011 Productos Marinos,C.A (Promarca) [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
09/12/2011 The Cherry Co., Ltd. [ARCHIVED] San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 08/02/2013
09/12/2011 Yag Mag Labs Private Limited [ARCHIVED] Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
09/12/2011 P.T. Intimas Surya [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP Not Issued *
09/09/2011 Zoka Coffee Company, LLC [ARCHIVED] Seattle District Office Current Good Manufacturing Practice Requirements for Foods/Adulterated 05/03/2012

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