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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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2013 Warning Letters

Posted on May 21, 2013

Letter Issue Date Company Name Issuing Office Subject Close Out Date
May 14, 2013 Whatsa Bagel, Inc. Baltimore District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
May 13, 2013 Robert L. Honeycutt Cincinnati District Office Illegal Drug Residue Not Issued *
May 09, 2013 Hospira Inc. Chicago District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 09, 2013 Kronner Prototypes, Inc Seattle District Office Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Not Issued *
May 08, 2013 Entrenet Nutritionals, Inc. Philadelphia District Office Unapproved and Misbranded New Drugs Not Issued *
May 06, 2013 Boehringer Ingelheim Pharma GMBH & Co Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
May 06, 2013 Rubimed AG Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 03, 2013 SmartPractice Center for Biologics Evaluation and Research False & Misleading Claims/Misbranded Not Issued *
May 02, 2013 Alternative Health Supplements Detroit District Office Unapproved and Misbranded New Drugs Not Issued *
May 02, 2013 WEBER MEDICAL GMBH Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
May 01, 2013 Pacific Harvest Seafoods, Inc. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 01, 2013 Dale Schmitmeyer Farm Cincinnati District Office Illegal Drug Residue Not Issued *
May 01, 2013 GRI Medical & Electronic Technology Co., Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
May 01, 2013 Riverpoint Medical, LLC Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
April 30, 2013 support@cigarettes-shop.net Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
April 30, 2013 Biocompatibles Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
April 30, 2013 http://www.cigarettes-info.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
April 30, 2013 Electromedical Products International, Inc Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
April 26, 2013 Pristine Bay LLC dba Vianda Cincinnati District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
April 26, 2013 ACell, Inc Baltimore District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *


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