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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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
07/03/2013 SCM True Air Technologies LLC Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
07/03/2013 Rusty Knoll Farm, Inc New England District Office Illegal Drug Residue Not Issued *
07/03/2013 Leroy C. Wormell, Jr. and Son, Inc. New England District Office Illegal Drug Residue Not Issued *
07/03/2013 Meridian Medical Systems LLC Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
07/02/2013 Cispharma Inc. New Jersey District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
07/02/2013 Chan Yee Jai Center for Food Safety and Applied Nutrition CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
07/02/2013 Productos Alimentios Centroamericanos, S.A. Center for Food Safety and Applied Nutrition CGMP/Acidified Foods/Adulterated 11/22/2013
07/01/2013 Fresenius Kabi Oncology Ltd Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
07/01/2013 NINGBO LINGGUANG ELECTRIC APPLIANCE CO., LTD. Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
07/01/2013 Sabila SRL Center for Food Safety and Applied Nutrition CGMP/Acidified Foods/Adulterated 10/17/2013
07/01/2013 Wesley Bourcy New York District Office Illegal Drug Residue Not Issued *
06/27/2013 AYGUN CERRAHI ALETIER A.S.SURGICAL INSTRUMENTS CO. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
06/26/2013 EvaPharmacy Center for Drug Evaluation and Research Internet Marketing of Unapproved and Misbranded Drugs Not Issued *
06/26/2013 Thompson Feedlot & Farms Denver District Office Illegal Drug Residue Not Issued *
06/25/2013 Graftys, S.A. Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded 03/10/2014
06/25/2013 Andi International Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
06/25/2013 Nutrient Synergy, Inc Denver District Office New Drug/Labeling/Misbranded Not Issued *
06/25/2013 Emanuel J. Lantz Philadelphia District Office Illegal Drug Residue 12/20/2013
06/24/2013 Clark Seafood Co, Inc New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
06/24/2013 KooJoo Trading Company Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
06/24/2013 North Dallas Honey Dallas District Office Labeling/New Drug/Misbranded Not Issued *
06/24/2013 H & D Farms Detroit District Office Illegal Drug Residue 02/24/2014
06/24/2013 Alpha Medical Instruments, LLC Los Angeles District Office Investigational Device Exemptions(IDE)/Premarket Approval Application (PMA) Not Issued *
06/21/2013 Celtrock Holdings Limited Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
06/20/2013 Lucky Board Manufacturing Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
06/20/2013 Janet K Tillisch, MD Center for Biologics Evaluation and Research Clinical Investigator-Human Trials   07/22/2013
06/19/2013 Rock Inn Dairy Minneapolis District Office Illegal Drug Residue 08/01/2013
06/19/2013 Transonic Systems Inc New York District Office Quality System Regulation for Medical Devices/Adulterated 01/16/2014
06/18/2013 Valley View Pork Detroit District Office Illegal Drug Residue 02/27/2014
06/18/2013 Herbs of Light, Inc. Florida District Office New Drugs/Dietary Supplements/Food Labeling/Misbranded 04/01/2014
06/17/2013 Formulife, Inc. Dallas District Office Unapproved New Drug/Adulterated/Misbranded Not Issued *
06/17/2013 Key Ingredient Market Philadelphia District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 02/11/2014
06/14/2013 L.A. Star Seafood Company, Inc. Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
06/14/2013 Biomedix, Inc. Detroit District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
06/14/2013 Levi M. Lapp Philadelphia District Office Illegal Drug Residue 12/17/2013
06/14/2013 East Bay Seafood Co., Inc. New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 01/30/2014
06/13/2013 Huvepharma Inc Kansas City District Office Medicated Feed/Adulterated Not Issued *
06/12/2013 Doft, Bernard H. M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
06/12/2013 GS Medical Packaging Inc Center for Devices and Radiological Health Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Not Issued *
06/12/2013 TYTEX SLOVAKIA S.R.O. Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded 07/18/2014
06/12/2013 Genesis BPS, LLC. New Jersey District Office Premarket Approval/Misbranded/Adulterated 03/11/2016
06/11/2013 Penn Pharmaceuticals Services Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated 10/30/2015
06/11/2013 Asahi Kasai Medical Co., Ltd. Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded 04/07/2014
06/10/2013 San Diego Cold Storage Dallas District Office Insanitary Conditions/Adulterated Not Issued *
06/10/2013 Muxlow Dairy Detroit District Office Illegal Drug Residue 03/24/2014
06/07/2013 Alma Lasers, Inc. Chicago District Office Medical Device Reporting/Misbranded 01/30/2014
06/06/2013 Constanza Agroindustrial, S.R.I. Center for Food Safety and Applied Nutrition Acidified Foods/Acid Canned Food Regulation/Adulterated 07/11/2013
06/06/2013 Ardounie Farms Philadelphia District Office Illegal Drug Residue 12/05/2013
06/06/2013 MEDINVENTS NV Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded 12/09/2014
06/06/2013 S Serra Cheese Company Detroit District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *

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