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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2012 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
February 22, 2012 Herman's Bakery Minneapolis District Office CGMP Regulation for Foods/Misbranded December 13, 2012
February 21, 2012 Scottcare Corporation Cincinnati District Office CGMP/QSR/Medical Device Reporting/Adulterated August 13, 2012
February 21, 2012 Fukuda Denshi Co, Ltd Center for Devices and Radiological Health CGMP for Medical Devices/QSR/Medical Device Reporting/Misbranded May 08, 2013
February 21, 2012 Wa Hen Dou Fu Soy Sauce Corporation San Francisco District Office CGMP Manufacture, Processing, Packing or Holding Food/Adulterated Not Issued *
February 21, 2012 Vascular Group PLLC Center for Devices and Radiological Health Clinical Investigator   August 03, 2012
February 17, 2012 Protica, Inc Philadelphia District Office CGMP/Acidified Foods/Dietary Supplement/Adulterated/Insanitary Conditions Not Issued *
February 17, 2012 Merck Sharp and Dohme Corp. Center for Drug Evaluation and Research Postmarket Requirements (PMRs) February 01, 2013
February 17, 2012 Winn Dixie Logistics, Inc. Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
February 17, 2012 Nu Garden, LLC Denver District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions May 22, 2014
February 17, 2012 Biochem Laboratories Inc. New Jersey District Office CGMP Regulations for Finished Pharmaceuticals/Adulterated November 18, 2013
February 16, 2012 Synthes USA HQ, Inc. Philadelphia District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
February 15, 2012 Octopus Garden, Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
February 15, 2012 Schwabe North America, Inc. Minneapolis District Office Unapproved New Drug/Misbranded Not Issued *
February 14, 2012 Omron (Dalian) Co., Ltd. Plant 1 Center for Devices and Radiological Health CGMP for Medical Devices/QSR/Medical Device Reporting/Adulterated Not Issued *
February 14, 2012 Ginsberg's Institutional Foods, Inc. New York District Office Seafood HACCP/Adulterated August 01, 2012
February 14, 2012 The Hershey Company Center for Food Safety and Applied Nutrition Food Labeling/Misbranded Not Issued *
February 14, 2012 Edge Biologicals, Inc. New Orleans District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
February 14, 2012 Jenis, Louis G., M.D. Center for Devices and Radiological Health Clinical Investigator Not Issued *
February 13, 2012 Meadowlark Dairy L.L.C. Minneapolis District Office Illegal Drug Residue April 13, 2012
February 12, 2012 I.E.M. GmbH Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *



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