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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
March 04, 2011 AZ Instrument (Shen Zhen) Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
March 04, 2011 AZ Instrument (Shen Zhen) Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
March 03, 2011 Eagle Diagnostics, Inc Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
March 03, 2011 2035, Inc. Minneapolis District Office Premarket Approval/Misbranded/Adulterate d Not Issued *
March 03, 2011 Eagle Diagnostics, Inc. Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
March 03, 2011 Queseria Chipilo, Inc. New Jersey District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions November 08, 2011
March 02, 2011 Four Sea's Inc. New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions June 22, 2011
March 02, 2011 Gaspari Nutrition, Inc. New Jersey District Office (CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated August 16, 2011
March 01, 2011 Willing's Group, Inc. New Jersey District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated October 27, 2011
March 01, 2011 Jaba Labs Center for Food Safety and Applied Nutrition Labeling/Dietary Supplements/Promotional Claims False & Misleading/Misbranded March 30, 2011
March 01, 2011 StarKist Company San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated July 26, 2013
February 28, 2011 Newport Lobster Company, Inc. New England District Office Seafood HAACP/CGMP for Foods/Adulterated October 24, 2011
February 28, 2011 Evershing International Trading Inc. San Francisco District Office Seafood HACCP August 02, 2013
February 25, 2011 Ohio Fresh Eggs LLC Cincinnati District Office Unsanitary Conditions/Adulterated December 06, 2011
February 25, 2011 Thurmond-Anderle, Margaret E. M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
February 25, 2011 Medela Inc Chicago District Office CGMP/QSR/Medical Devices/Adulterated April 14, 2014
February 25, 2011 Cenova Innovation and Productions AB Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated August 13, 2014
February 24, 2011 Gordon Food Service, Inc. Detroit District Office Seafood HACCP/Adulterated January 17, 2012
February 24, 2011 InSight Dairy, LLC. New York District Office Animals for Sale for Slaughter as Food/Adulterated Not Issued *
February 23, 2011 Sunrise Orchards Inc Detroit District Office CGMP for Foods/Seafood HACCP/Adulterated November 05, 2013



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