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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 18, 2011 Caridian BCT Inc. Denver District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated November 21, 2011
March 18, 2011 Pt. Indomaguro Tunas Unggul Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
March 18, 2011 Horizon Acres Cincinnati District Office Animals for Sale for Slaughter as Food/Adulterated Not Issued *
March 18, 2011 Non-Invasive Monitoring Systems, Inc. Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated June 24, 2013
March 17, 2011 Dakota Laboratories, Llc Minneapolis District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
March 16, 2011 Airline Seafood, Inc. Dallas District Office Seafood HACCP/Adulterated September 06, 2013
March 16, 2011 Eidosmed Chicago District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
March 14, 2011 Galati Cheese Company Ltd. Center for Food Safety and Applied Nutrition CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *
March 14, 2011 R82 A/S Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
March 14, 2011 Griffin, John M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
March 14, 2011 Health Robotics Srl Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated May 17, 2013
March 11, 2011 Shemshad Food Products, Inc Los Angeles District Office CGMP Food Labeling/False & Misleading/Claims Misbranded & Acidified Foods/Adulterated Not Issued *
March 11, 2011 Cajun Crab, LLC New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated May 24, 2012
March 09, 2011 BioSculptor Corporation Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
March 09, 2011 PT. Tuna Permata Rezeki Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
March 08, 2011 Rebuilder Medical, Inc. Baltimore District Office CGMP/QSR/Medical Devices/Adulterated August 10, 2011
March 08, 2011 Wimberger's Old World Bakery Denver District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
March 04, 2011 Goetze's Candy Company Inc Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Misbranded 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 04, 2011 AZ Instrument (Shen Zhen) Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *



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