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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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
03/09/2012 Sebastian Joe's Ice Cream Commissary Minneapolis District Office Food Labeling Misbranded 08/26/2014
03/09/2012 Laboratorios Jaloma S.A. de C.V. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated 07/01/2014
03/09/2012 Cosmed S.R.L. Center for Devices and Radiological Health CGMP for Medical Devices/QSR/Medical Device Reporting/Misbranded Not Issued *
03/08/2012 Warner Chilcott Company, LLC San Juan District Office CGMP Regulations for Finished Pharmaceuticals/Adulterated 06/07/2013
03/07/2012 Staples, Incorporated San Francisco District Office CGMP for Foods/Adulterated 07/27/2012
03/07/2012 Heartway Medical Products Co., Ltd. Center for Devices and Radiological Health CGMP for Medical Devices/QSR/Medical Device Reporting/Adulterated 07/16/2015
03/07/2012 Nobilus Ent Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Adulterated 06/05/2015
03/07/2012 Fong Kee Tofu Company, Inc. San Francisco District Office CGMP Regulation for Foods/Misbranded Not Issued *
03/07/2012 Osypka Medical GmbH Center for Devices and Radiological Health CGMP for Medical Devices/QSR/Medical Device Reporting/Adulterated/Misbranded Not Issued *
03/07/2012 Zhong Shun Inc. Los Angeles District Office Seafood HACCP/Adulterated Not Issued *
03/07/2012 Modern Products, Inc. Minneapolis District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated 09/05/2013
03/06/2012 Griebel Dairy Farms Philadelphia District Office Illegal Drug Residue 01/11/2013
03/06/2012 Box Canyon Dairy Seattle District Office Illegal Drug Residue Not Issued *
03/06/2012 SystemsOne, LLC Florida District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded Not Issued *
03/06/2012 JBS USA Holdings dba JBS Distributing Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
03/05/2012 Breathable Foods, Inc. New England District Office False & Misleading Claims/Misbranded Not Issued *
03/02/2012 Dorsey Farms, Inc. Seattle District Office Illegal Drug Residue Not Issued *
03/02/2012 Fog River, LLC Denver District Office Seafood HACCP/CGMP for Foods/Adulterated 11/21/2012
03/02/2012 Hill-Rom, Inc. Detroit District Office CGMP/QSR/Medical Devices/Adulterated 09/10/2015
03/02/2012 General Tuna Corporation Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
02/28/2012 Prosec Protection Systems, Inc. New Jersey District Office CGMP for Medical Devices/QS/Adulterated Not Issued *
02/28/2012 Pan Drugs Limited Center for Drug Evaluation and Research Failure to Register and List 10/18/2012
02/27/2012 Sir Pizza of Tennessee, Inc. New Orleans District Office Current Good Manufacturing Practice in Manufacturing Packing or Holding Human Food/Adulterated 06/14/2012
02/24/2012 Butternut Brook Farm New York District Office Illegal Drug Residue Not Issued *
02/24/2012 Fells Point Wholesale Meats, Inc. Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
02/24/2012 Extremity Medical, LLC New Jersey District Office Medical Device Reporting Regulation/Adulterated/Misbranded 11/26/2012
02/23/2012 Medica-Rents Co., Ltd. Dallas District Office CGMP/QSR/Medical Devices/Adulterated 01/29/2013
02/23/2012 Lucomed Spa Center for Devices and Radiological Health CMGP for Medical Devices/QSR/Medical Device Reporting/Misbranded Not Issued *
02/23/2012 Gulf Pharmaceutical Industries Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated, Not Issued *
02/23/2012 Shanghai Apolo Medical Technology Co., Ltd Center for Devices and Radiological Health Adulterated Device 06/26/2014
02/23/2012 Life Recovery Systems HD, LLC New Jersey District Office CGMP/QSR/Medical Devices/Adulterated 09/25/2012
02/23/2012 Innovatech Medical Resources L.P. d/b/a Medical Services International (MSI) Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
02/23/2012 Wintac Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated 06/18/2014
02/22/2012 Herman's Bakery Minneapolis District Office CGMP Regulation for Foods/Misbranded 12/13/2012
02/22/2012 Dale's LLC Denver District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 05/22/2014
02/22/2012 APP Pharmaceuticals, LLC New York District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
02/21/2012 Vascular Group PLLC Center for Devices and Radiological Health Clinical Investigator   08/03/2012
02/21/2012 Fukuda Denshi Co, Ltd Center for Devices and Radiological Health CGMP for Medical Devices/QSR/Medical Device Reporting/Misbranded 05/08/2013
02/21/2012 Scottcare Corporation Cincinnati District Office CGMP/QSR/Medical Device Reporting/Adulterated 08/13/2012
02/21/2012 Wa Hen Dou Fu Soy Sauce Corporation San Francisco District Office CGMP Manufacture, Processing, Packing or Holding Food/Adulterated Not Issued *
02/17/2012 Protica, Inc Philadelphia District Office CGMP/Acidified Foods/Dietary Supplement/Adulterated/Insanitary Conditions Not Issued *
02/17/2012 Nu Garden, LLC Denver District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 05/22/2014
02/17/2012 Winn Dixie Logistics, Inc. Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
02/17/2012 Biochem Laboratories Inc. New Jersey District Office CGMP Regulations for Finished Pharmaceuticals/Adulterated 11/18/2013
02/17/2012 Merck Sharp and Dohme Corp. Center for Drug Evaluation and Research Postmarket Requirements (PMRs) 02/01/2013
02/16/2012 Synthes USA HQ, Inc. Philadelphia District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
02/15/2012 Schwabe North America, Inc. Minneapolis District Office Unapproved New Drug/Misbranded Not Issued *
02/15/2012 Octopus Garden, Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
02/14/2012 Jenis, Louis G., M.D. Center for Devices and Radiological Health Clinical Investigator Not Issued *
02/14/2012 Ginsberg's Institutional Foods, Inc. New York District Office Seafood HACCP/Adulterated 08/01/2012

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