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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

2012 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
September 07, 2012 SR Rosati, Inc. Philadelphia District Office CGMP Regulation For Foods/Adulterated/Misbranded February 28, 2013
September 07, 2012 Lancome Center for Food Safety and Applied Nutrition New Drug Application [NDA] November 19, 2012
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 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 06, 2012 Quzhou Chemsyn Pharm Co Ltd Center for Drug Evaluation and Research Failure to Register and List  Not Issued *
September 06, 2012 Thelen Livestock (Brad Thelen) Minneapolis District Office Illegal Drug Residue March 26, 2013
September 06, 2012 Twin Oaks Dairy, LLC Philadelphia District Office Illegal Drug Residue March 04, 2013
September 05, 2012 Atlanta Dental Supply Company, Inc . Atlanta District Office X-Ray Systems Not Issued *
September 05, 2012 Yangpo Foods Co.,Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
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 MDK Enterprises, Inc dba Maui Jelly Factory San Francisco District Office Acidified Foods/Adulterated August 07, 2013
September 05, 2012 Petaluma Farms San Francisco District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
September 05, 2012 John Joseph Hewett, M.D. Center for Devices and Radiological Health Institutional Review Board (IRB)/Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device Not Issued *
September 05, 2012 Synergy Health Concepts, Inc Center for Devices and Radiological Health Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device/Institutional Review Board (IRB) Not Issued *
September 05, 2012 Hyphen BioMed Center for Devices and Radiological Health Quality System Regulation for Medical Devices/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 Aino Co., Ltd. of North China Pharmaceutical Group Center for Drug Evaluation and Research Failure to register and list December 14, 2012
August 30, 2012 Hohberg Poultry Ranch F1/F2 Los Angeles District Office PHS Act/Shell Egg Regulation/Adulterated/Insanitary Conditions Not Issued *



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