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

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