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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
09/12/2012 The Santa Barbara Smokehouse, Inc. Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
09/12/2012 Noble Anesthesia-Air, Inc. Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
09/12/2012 St. James Smokehouse Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 06/24/2013
09/12/2012 C.C. & Son Farms, Incorporated San Francisco District Office PHS Act/Violation/Adulterated Not Issued *
09/11/2012 Mir-Com Products LLC Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated 03/12/2013
09/11/2012 Roberts Ranch of Oklahoma LLC Dallas District Office Illegal Drug Residue 09/25/2013
09/11/2012 EPS Biotechnology Corp. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 10/31/2013
09/10/2012 Gyrus ACMI, Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
09/10/2012 Monarch Seafoods, Inc. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated 11/25/2013
09/10/2012 Global Source Management & Consulting Florida District Office New Drugs/Dietary Supplements/Food Labeling/Misbranded Not Issued *
09/07/2012 Chassy Bagels, Inc. dba House of Bagels, Inc. San Francisco District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *
09/07/2012 Fercy Personal Care Products Co., Ltd Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated & Failure to Register and List Not Issued *
09/07/2012 Lancome Center for Food Safety and Applied Nutrition New Drug Application [NDA] 11/19/2012
09/07/2012 www.cheapindonesiacigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 11/07/2012
09/07/2012 SR Rosati, Inc. Philadelphia District Office CGMP Regulation For Foods/Adulterated/Misbranded 02/28/2013
09/07/2012 www.cigarettes-for-less.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/07/2012 Greek Island Labs Center for Food Safety and Applied Nutrition New Drug Application [NDA] Not Issued *
09/07/2012 Unisis Corporation Center for Devices and Radiological Health CGMP/QSR/Medical Device Reporting/Adulterated/Misbranded Not Issued *
09/06/2012 Quzhou Chemsyn Pharm Co Ltd Center for Drug Evaluation and Research Failure to Register and List  Not Issued *
09/06/2012 Twin Oaks Dairy, LLC Philadelphia District Office Illegal Drug Residue 03/04/2013
09/06/2012 Thelen Livestock (Brad Thelen) Minneapolis District Office Illegal Drug Residue 03/26/2013
09/05/2012 John Joseph Hewett, M.D. Center for Devices and Radiological Health Clinical Investigator - Human Trials Not Issued *
09/05/2012 Synergy Health Concepts, Inc Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization Not Issued *
09/05/2012 Hyphen BioMed Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated 10/24/2016
09/05/2012 Atlanta Dental Supply Company, Inc . Atlanta District Office X-Ray Systems Not Issued *
09/05/2012 Petaluma Farms San Francisco District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
09/05/2012 MDK Enterprises, Inc dba Maui Jelly Factory San Francisco District Office Acidified Foods/Adulterated 08/07/2013
09/05/2012 Trans-Pacific Assets Management Inc. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
09/05/2012 Yangpo Foods Co.,Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
08/31/2012 Persimmon Hill Farm Gourmet Foods Kansas City District Office Juice HACCP/Acidified Foods/Adulterated Not Issued *
08/31/2012 Sam & Son Wholesale Group, Inc. Atlanta District Office CGMP Regulation for Foods/Adulterated Not Issued *
08/30/2012 Hohberg Poultry Ranch F1/F2 Los Angeles District Office PHS Act/Shell Egg Regulation/Adulterated/Insanitary Conditions 04/28/2014
08/30/2012 Fresh Mushroom Farm Inc Kansas City District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 11/22/2013
08/30/2012 Aino Co., Ltd. of North China Pharmaceutical Group Center for Drug Evaluation and Research Failure to register and list 12/14/2012
08/29/2012 Sea One Enterprises, Inc. Cincinnati District Office CGMP for Foods/Adulterated Not Issued *
08/28/2012 Rell & Renn Seafood Sphere, Inc. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated 10/23/2012
08/28/2012 Creation's Garden Natural Products, Inc. Los Angeles District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
08/28/2012 Blends Maker Mfg Inc. San Juan District Office HACCP/Adulterated 06/30/2017
08/28/2012 Wendell Corporation dba Regalo Bakery San Francisco District Office CGMP Regulation for Foods/Adulterated 09/18/2013
08/28/2012 Trinity Sports Group, Inc. Dallas District Office New Drug/Labeling/Misbranded Not Issued *
08/28/2012 Regeneca, Inc Los Angeles District Office Dietary Supplement/Adulterated Not Issued *
08/27/2012 Indus Enterprises, Inc. d/b/a Texas Jasmine Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 10/16/2012
08/27/2012 DPT Lakewood, LLC New Jersey District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded 02/19/2013
08/27/2012 Naturavit, Inc. Florida District Office CGMP For Manufacturing, Packing, Labeling, or Holding for Dietary Supplements/Adulterated/Misbranded Not Issued *
08/27/2012 Cendano Corporation Ltd. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/27/2012 PruTect Rx Denver District Office New Drug/Labeling/Misbranded 08/29/2013
08/24/2012 Merge Healthcare New Orleans District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
08/23/2012 Instratek, Incorporated Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
08/23/2012 Marks Marine Pharmacy Center for Drug Evaluation and Research Unapproved and Misbranded New Drugs Not Issued *
08/23/2012 Madeleine Rausis Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *

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