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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

2013 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
June 14, 2013 Biomedix, Inc. Detroit District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
June 14, 2013 East Bay Seafood Co., Inc. New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions January 30, 2014
June 14, 2013 L.A. Star Seafood Company, Inc. Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
June 14, 2013 Levi M. Lapp Philadelphia District Office Illegal Drug Residue December 17, 2013
June 13, 2013 Huvepharma Inc Kansas City District Office Medicated Feed/Adulterated Not Issued *
June 12, 2013 GS Medical Packaging Inc Center for Devices and Radiological Health Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Not Issued *
June 12, 2013 Bernard H. Doft, M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
June 12, 2013 TYTEX SLOVAKIA S.R.O. Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
June 12, 2013 Genesis BPS, LLC. New Jersey District Office Premarket Approval/Misbranded/Adulterated Not Issued *
June 11, 2013 Penn Pharmaceuticals Services Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
June 11, 2013 Asahi Kasai Medical Co., Ltd. Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded April 07, 2014
June 10, 2013 Muxlow Dairy Detroit District Office Illegal Drug Residue March 24, 2014
June 10, 2013 San Diego Cold Storage Dallas District Office Insanitary Conditions/Adulterated Not Issued *
June 07, 2013 Alma Lasers, Inc. Chicago District Office Medical Device Reporting/Misbranded January 30, 2014
June 06, 2013 Constanza Agroindustrial, S.R.I. Center for Food Safety and Applied Nutrition Acidified Foods/Acid Canned Food Regulation/Adulterated July 11, 2013
June 06, 2013 Ardounie Farms Philadelphia District Office Illegal Drug Residue December 05, 2013
June 06, 2013 MEDINVENTS NV Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
June 06, 2013 S Serra Cheese Company Detroit District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
June 05, 2013 Henry A Frazer, Pharm D, Clinical Investigator Center for Drug Evaluation and Research Clinical Investigator Not Issued *
June 05, 2013 Baarda Farms Seattle District Office Illegal Drug Residue Not Issued *



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