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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2013 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
June 18, 2013 Herbs of Light, Inc. Florida District Office New Drugs/Dietary Supplements/Food Labeling/Misbranded April 01, 2014
June 18, 2013 Valley View Pork Detroit District Office Illegal Drug Residue February 27, 2014
June 17, 2013 Formulife, Inc. Dallas District Office Unapproved New Drug/Adulterated/Misbranded Not Issued *
June 17, 2013 Key Ingredient Market Philadelphia District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions February 11, 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 Biomedix, Inc. Detroit District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
June 14, 2013 Levi M. Lapp Philadelphia District Office Illegal Drug Residue December 17, 2013
June 14, 2013 East Bay Seafood Co., Inc. New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions January 30, 2014
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 Genesis BPS, LLC. New Jersey District Office Premarket Approval/Misbranded/Adulterated Not Issued *
June 12, 2013 TYTEX SLOVAKIA S.R.O. Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded July 18, 2014
June 12, 2013 Bernard H. Doft, M.D. Center for Drug Evaluation and Research Clinical Investigator 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 11, 2013 Penn Pharmaceuticals Services Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
June 10, 2013 San Diego Cold Storage Dallas District Office Insanitary Conditions/Adulterated Not Issued *
June 10, 2013 Muxlow Dairy Detroit District Office Illegal Drug Residue March 24, 2014
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 MEDINVENTS NV Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *



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