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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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
January 29, 2013 CryoLife, Inc. Atlanta District Office CGMP/QSR/Medical Devices/Adulterated April 23, 2015
January 29, 2013 FSSB Chirurgische Nadeln Gmbh Center for Devices and Radiological Health Quality System Regulation/Medical Device Reporting/Adulterated August 06, 2015
January 28, 2013 Bacterin International, Inc. Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
January 28, 2013 Paul K Katzmaier Philadelphia District Office Illegal Drug Residue July 11, 2013
January 28, 2013 Bacterin International, Inc. Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded September 18, 2013
January 25, 2013 Correia Dairy San Francisco District Office Illegal Drug Residue Not Issued *
January 25, 2013 NX Generation Ltd. New York District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
January 25, 2013 R & D Ranch San Francisco District Office Illegal Drug Residue Not Issued *
January 25, 2013 SciLabs Nutraceuticals Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
January 25, 2013 Tecval Medical Sarl Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
January 24, 2013 Flu & Cold Defense LLC Center for Drug Evaluation and Research Unapproved Products Related to the 2012/2013 Flu Season Not Issued *
January 23, 2013 ASI Medical, Inc. Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) April 12, 2013
January 23, 2013 Gills Onions, LLC Los Angeles District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions November 29, 2013
January 23, 2013 Walk, Ed Chicago District Office Illegal Drug Residue Not Issued *
January 23, 2013 Gioia Cheese Company Inc. Los Angeles District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
January 23, 2013 Spes Medica Srl Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
January 23, 2013 Herdering, Steven Minneapolis District Office Illegal Drug Residue April 19, 2013
January 22, 2013 Manchester Veal, LLC dba Calf Start Detroit District Office Illegal Drug Residue April 11, 2013
January 18, 2013 Rancho Cantera Chicago District Office Illegal Drug Residue Not Issued *
January 18, 2013 Renati Dairy San Francisco District Office Illegal Drug Residue Not Issued *

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