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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
October 05, 2011 Island Desserts LLC New England District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions July 13, 2012
October 04, 2011 Akers Biosciences, Inc. New Jersey District Office Premarket Approval/Adulterated September 27, 2012
October 04, 2011 Oridion Medical 1987 Ltd. Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
October 04, 2011 Advantageous Md Llc Baltimore District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
September 30, 2011 GRAND BK CORP. New York District Office Seafood HACCP/CGMP for Foods/Adulterated March 23, 2012
September 30, 2011 El Chilerito Spice Co. Inc. Los Angeles District Office Food/Labeling/Misbranded Not Issued *
September 30, 2011 Vitalie Rotaru Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
September 30, 2011 Repostería Aymat, Inc. San Juan District Office CGMP For Manufacturing, Packing,or Holding Food/Adulterated/Misbranded September 27, 2013
September 29, 2011 Villa Tatra, Inc. Denver District Office Seafood HACCP/CGMP for Foods/Adulterated September 10, 2012
September 29, 2011 DJ Tuna Express Inc. Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
September 29, 2011 Donuts Deluxe Minneapolis District Office Food Labeling Misbranded April 20, 2012
September 28, 2011 Lebanese Arak Corp Los Angeles District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
September 27, 2011 Cantor & Nissel Ltd. Center for Devices and Radiological Health Adulterated Device/Misbranding/Quality Control Not Issued *
September 27, 2011 Middlesboro Appalachian Regional Hospital Cincinnati District Office Mammography Quality Standards Act Not Issued *
September 26, 2011 Aesculap AG Center for Devices and Radiological Health Adulterated Device/Misbranded November 13, 2013
September 23, 2011 K. Heeps, Inc Philadelphia District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions March 13, 2012
September 23, 2011 X-Ray Support, Inc. Seattle District Office CGMP For Manufacturing, Packing, Storage or Installation/Adulterated Not Issued *
September 22, 2011 Florida Fruit Juices, Inc. Chicago District Office Food Labeling/Misbranded September 10, 2012
September 22, 2011 Herbal Nitro Inc. Los Angeles District Office CGMP For Manufacturing, Packaging, Labeling, or Holding for Dietary Supplements/Adulterated April 03, 2013
September 21, 2011 SPHERE Inc. Center for Drug Evaluation and Research Unapproved and Misbranded New Drugs Not Issued *



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