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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 Shen Clinic, LLC. San Francisco District Office New Drug/Misbranded November 27, 2013
May 14, 2013 Hyman Farms Dallas District Office Illegal Drug Residue May 16, 2014
May 14, 2013 Zi Xiu Tang Success, LLC Philadelphia District Office Unapproved and Misbranded New Drugs December 06, 2013
May 14, 2013 Medys S.p.A. Center for Devices and Radiological Health Adulterated Device Not Issued *
May 14, 2013 Whatsa Bagel, Inc. Baltimore District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions August 04, 2014
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 George Boere Dairy Los Angeles District Office Illegal Drug Residue 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 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 Apnea Sciences Inc Los Angeles District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
May 08, 2013 LISA Laser Products OHG Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
May 08, 2013 Entrenet Nutritionals, Inc. Philadelphia District Office Unapproved and Misbranded New Drugs 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 *



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