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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 01, 2013 Fresenius Kabi Oncology Ltd Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
July 01, 2013 Sabila SRL Center for Food Safety and Applied Nutrition CGMP/Acidified Foods/Adulterated October 17, 2013
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 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 Thompson Feedlot & Farms Denver District Office Illegal Drug Residue Not Issued *
June 26, 2013 EvaPharmacy Center for Drug Evaluation and Research Internet Marketing of Unapproved and Misbranded Drugs Not Issued *
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 Graftys, S.A. Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded March 10, 2014
June 25, 2013 Emanuel J. Lantz Philadelphia District Office Illegal Drug Residue December 20, 2013
June 25, 2013 Nutrient Synergy, Inc Denver District Office New Drug/Labeling/Misbranded Not Issued *
June 24, 2013 Clark Seafood Co, Inc New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
June 24, 2013 North Dallas Honey Dallas District Office Labeling/New Drug/Misbranded 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 Alpha Medical Instruments, LLC Los Angeles District Office Investigational Device Exemptions(IDE)/Premarket Approval Application (PMA) Not Issued *
June 24, 2013 H & D Farms Detroit District Office Illegal Drug Residue February 24, 2014
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 Transonic Systems Inc New York District Office Quality System Regulation for Medical Devices/Adulterated January 16, 2014

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