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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
July 01, 2013 Sabila SRL Center for Food Safety and Applied Nutrition CGMP/Acidified Foods/Adulterated October 17, 2013
July 01, 2013 Fresenius Kabi Oncology Ltd Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated 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 New Animal Drug/Adulterated 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 H & D Farms Detroit District Office Illegal Drug Residue February 24, 2014
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 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 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 Janet K Tillisch, MD Center for Biologics Evaluation and Research Bioresearch Monitoring Program/IRB   July 22, 2013
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 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 Herbs of Light, Inc. Florida District Office New Drugs/Dietary Supplements/Food Labeling/Misbranded April 01, 2014



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