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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
July 03, 2013 Rusty Knoll Farm, Inc New England District Office Illegal Drug Residue Not Issued *
July 03, 2013 Leroy C. Wormell, Jr. and Son, Inc. New England District Office Illegal Drug Residue Not Issued *
July 03, 2013 Meridian Medical Systems LLC Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
July 02, 2013 Cispharma Inc. New Jersey District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
July 02, 2013 Chan Yee Jai Center for Food Safety and Applied Nutrition CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
July 02, 2013 Productos Alimentios Centroamericanos, S.A. Center for Food Safety and Applied Nutrition CGMP/Acidified Foods/Adulterated November 22, 2013
July 01, 2013 Fresenius Kabi Oncology Ltd Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
July 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 *
July 01, 2013 Sabila SRL Center for Food Safety and Applied Nutrition CGMP/Acidified Foods/Adulterated October 17, 2013
July 01, 2013 Wesley Bourcy New York District Office Illegal Drug Residue Not Issued *
June 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 *
June 26, 2013 EvaPharmacy Center for Drug Evaluation and Research Internet Marketing of Unapproved and Misbranded Drugs Not Issued *
June 26, 2013 Thompson Feedlot & Farms Denver District Office Illegal Drug Residue Not Issued *
June 25, 2013 Graftys, S.A. Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded March 10, 2014
June 25, 2013 Andi International Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
June 25, 2013 Nutrient Synergy, Inc Denver District Office New Drug/Labeling/Misbranded Not Issued *
June 25, 2013 Emanuel J. Lantz Philadelphia District Office Illegal Drug Residue December 20, 2013
June 24, 2013 Clark Seafood Co, Inc New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
June 24, 2013 KooJoo Trading Company Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
June 24, 2013 North Dallas Honey Dallas District Office Labeling/New Drug/Misbranded Not Issued *
June 24, 2013 H & D Farms Detroit District Office Illegal Drug Residue February 24, 2014
June 24, 2013 Alpha Medical Instruments, LLC Los Angeles District Office Investigational Device Exemptions(IDE)/Premarket Approval Application (PMA) Not Issued *
June 21, 2013 Celtrock Holdings Limited Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
June 20, 2013 Lucky Board Manufacturing Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
June 20, 2013 Janet K Tillisch, MD Center for Biologics Evaluation and Research Clinical Investigator-Human Trials   July 22, 2013
June 19, 2013 Rock Inn Dairy Minneapolis District Office Illegal Drug Residue August 01, 2013
June 19, 2013 Transonic Systems Inc New York District Office Quality System Regulation for Medical Devices/Adulterated January 16, 2014
June 18, 2013 Valley View Pork Detroit District Office Illegal Drug Residue February 27, 2014
June 18, 2013 Herbs of Light, Inc. Florida District Office New Drugs/Dietary Supplements/Food Labeling/Misbranded April 01, 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 Doft, Bernard H. M.D. Center for Drug Evaluation and Research Clinical Investigator 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 TYTEX SLOVAKIA S.R.O. Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded July 18, 2014
June 12, 2013 Genesis BPS, LLC. New Jersey District Office Premarket Approval/Misbranded/Adulterated March 11, 2016
June 11, 2013 Penn Pharmaceuticals Services Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated October 30, 2015
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 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 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 December 09, 2014
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 Baarda Farms Seattle District Office Illegal Drug Residue Not Issued *

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