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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 14, 2013 Medys S.p.A. Center for Devices and Radiological Health Adulterated Device Not Issued *
May 14, 2013 Zi Xiu Tang Success, LLC Philadelphia District Office Unapproved and Misbranded New Drugs December 06, 2013
May 14, 2013 Whatsa Bagel, Inc. Baltimore District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions August 04, 2014
May 14, 2013 Joseph-Vempilly, Jose, MD Center for Drug Evaluation and Research Clinical Investigator Not Issued *
May 13, 2013 Robert L. Honeycutt Cincinnati District Office Illegal Drug Residue Not Issued *
May 10, 2013 Superex Canada Ltd Center for Devices and Radiological Health Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Not Issued *
May 09, 2013 Kronner Prototypes, Inc Seattle District Office Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Not Issued *
May 09, 2013 Hospira Inc. Chicago District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 09, 2013 Valley Health/Winchester Medical Center IRB Center for Devices and Radiological Health Investigational Review Board (IRB) Not Issued *
May 09, 2013 George Boere Dairy Los Angeles District Office Illegal Drug Residue Not Issued *
May 09, 2013 Apnea Sciences Inc Los Angeles District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
May 08, 2013 Entrenet Nutritionals, Inc. Philadelphia District Office Unapproved and Misbranded New Drugs Not Issued *
May 08, 2013 LISA Laser Products OHG Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
May 07, 2013 The Standing Company Detroit District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 07, 2013 Standard Textile Co Inc Cincinnati District Office Premarket Approval/Misbranded/Adulterated June 24, 2013
May 06, 2013 Rubimed AG Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 06, 2013 Boehringer Ingelheim Pharma GMBH & Co Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated June 05, 2014
May 06, 2013 Invatec S.p.A. Center for Devices and Radiological Health Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Not Issued *
May 03, 2013 SmartPractice Center for Biologics Evaluation and Research False & Misleading Claims/Misbranded Not Issued *
May 02, 2013 Earthborn Products, Inc. Los Angeles District Office New Drug/Labeling/Misbranded Not Issued *



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