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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
May 24, 2013 Crop Pharms New York District Office Unapproved and Misbranded New Drugs Not Issued *
May 24, 2013 Edwards Lifesciences, LLC Denver District Office CGMP/QSR/Medical Device Reporting/Adulterated Not Issued *
May 24, 2013 ConvaTec Inc. New Jersey District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 24, 2013 Sundial Herbal Products New York District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
May 22, 2013 American Seaway Foods Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 22, 2013 Swedish Match North America Inc Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
May 22, 2013 Metaugus Inc Atlanta District Office Dietary Supplement/Adulterated Not Issued *
May 22, 2013 Bradley M. Burton Cincinnati District Office Illegal Drug Residue Not Issued *
May 21, 2013 Teeter Creek Herbs, Inc Kansas City District Office Dietary Supplement/Labeling/False & Misleading Claims/Misbranded Not Issued *
May 21, 2013 So-Low Environmental Equipment Co. Inc. Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 21, 2013 JLM Manufacturing LLC Detroit District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions January 31, 2014
May 17, 2013 Contract Pharmaceutical Services of Australia Pty Ltd Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
May 17, 2013 K S Choi Corp Los Angeles District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
May 16, 2013 Matrix Health Products Seattle District Office Internet Marketing of Unapproved and Misbranded Drugs Not Issued *
May 16, 2013 Ortho-Cycle Company Inc. Florida District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
May 15, 2013 Gexfix SA Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 15, 2013 www.smokinforfree.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
May 15, 2013 Custom Compounding Centers, LLC Los Angeles District Office Unapproved and Misbranded New Drugs Not Issued *
May 15, 2013 www.get-cheap-cigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
May 14, 2013 Joseph-Vempilly, Jose, MD Center for Drug Evaluation and Research Clinical Investigator Not Issued *



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