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

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