Inspections, Compliance, Enforcement, and Criminal Investigations
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2012 Warning Letters
Posted on March 27, 2012
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
February 17, 2012 | Winn Dixie Logistics, Inc. | Florida District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Not Issued * |
February 17, 2012 | Biochem Laboratories Inc. | New Jersey District Office | CGMP Regulations for Finished Pharmaceuticals/Adulterated | Not Issued * |
February 16, 2012 | Synthes USA HQ, Inc. | Philadelphia District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | Not Issued * |
February 15, 2012 | Schwabe North America, Inc. | Minneapolis District Office | Unapproved New Drug/Misbranded | Not Issued * |
February 15, 2012 | Octopus Garden, Inc. | New York District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | 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 | 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 | Bioresearch Monitoring Program/IRB | Not Issued * |
February 14, 2012 | Ginsberg's Institutional Foods, Inc. | New York District Office | Seafood HACCP/Adulterated | August 01, 2012 |
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