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

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