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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

2013 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
September 19, 2013 Insight Pharmaceuticals Corporation Philadelphia District Office Labeling/False & Misleading Claims/Misbranded Not Issued *
September 19, 2013 Homeolab Inc. Center for Drug Evaluation and Research Labeling/False & Misleading Claims/Misbranded Not Issued *
September 19, 2013 Medtronic MiniMed Center for Devices and Radiological Health Quality System Regulation for Medical Device Reporting/Adulterated/Misbranded Not Issued *
September 19, 2013 www.cheapcigsonline.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
September 19, 2013 www.dynamicwd.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded November 07, 2013
September 19, 2013 Topco Assoc Chicago District Office Labeling/False & Misleading Claims/Misbranded Not Issued *
September 19, 2013 Medtech Products, Inc. New York District Office Labeling/False & Misleading Claims/Misbranded Not Issued *
September 19, 2013 Herbalist and Alchemist, Inc. New Jersey District Office CGMP/Dietary Supplement/Adulterated Not Issued *
September 19, 2013 Dolgencorp Inc New Orleans District Office Labeling/False & Misleading Claims/Misbranded Not Issued *
September 19, 2013 ANJI ZHENGBANG MEDICAL INSTRUMENT CO, LTD Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
September 18, 2013 General Hearing Instruments Inc New Orleans District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
September 17, 2013 Cheshire Valley Farms LLC New York District Office Illegal Drug Residue Not Issued *
September 17, 2013 C.P.M. Contract Pharma GmbH & Co. KG Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) January 14, 2014
September 17, 2013 Slate River Ranch LLC Dallas District Office Illegal Drug Residue Not Issued *
September 16, 2013 Epflex Feinwerktechnik GmbH Center for Devices and Radiological Health Quality System Regulation for Medical Device Reporting/Adulterated/Misbranded Not Issued *
September 16, 2013 Machia and Sons Dairy, LLC New England District Office Illegal Drug Residue Not Issued *
September 16, 2013 Suzhou Armocon Technology Co. Ltd Center for Devices and Radiological Health Quality System Regulation for Medical Device Reporting/Adulterated/Misbranded Not Issued *
September 13, 2013 Bella Holsteins, Incorporated Denver District Office Illegal Drug Residue Not Issued *
September 13, 2013 Samuel A. Fisher Farm Philadelphia District Office Illegal Drug Residue March 03, 2014
September 12, 2013 Dimitri Sirakoff Center for Drug Evaluation and Research Clinical Investigator Not Issued *



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