• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

2012 Warning Letters

 
-
Letter Issue Date Company Name Issuing Office Subject Close Out Date
01/13/2012 Shandong Zibo Shanchuan Medical Instrument Co. Ltd. Center for Devices and Radiological Health CGMP for Medical Devices/QSR/Medical Device Reporting/Adulterated/Misbranded Not Issued *
01/13/2012 Blount Seafood Corporation New England District Office Seafood HACCP/CGMP for Foods/Adulterated 05/31/2013
01/13/2012 LeCaptain, Mark D. Minneapolis District Office Illegal Drug Residue 02/27/2012
01/12/2012 Augusta Medical Systems, LLC Atlanta District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
01/12/2012 Soring Medical Technology Florida District Office Medical Device Reporting/Misbranded Not Issued *
01/12/2012 Health Science Products Inc New Orleans District Office Medical Device Reporting/Misbranded Not Issued *
01/11/2012 S W Seafood, Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 09/04/2012
01/11/2012 Galhano Dairy San Francisco District Office Illegal Drug Residue Not Issued *
01/10/2012 Progressive Medical Inc Kansas City District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded 08/03/2012
01/10/2012 Agora Publishing Inc Baltimore District Office New Drug/Labeling/Misbranded Not Issued *
01/09/2012 Orthotics & Prosthetics One Inc Kansas City District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated 01/29/2015
01/09/2012 Medical Quant USA Cincinnati District Office Premarket Approval/Adulterated 11/01/2012
01/06/2012 Royal Domains Atlanta District Office Unapproved New Drugs/Misbranded Dietary Supplements Not Issued *
01/06/2012 Advanced Orthogonal Equipment, Inc. Florida District Office QSR/Medical Devices/Adulterated Not Issued *
01/06/2012 BEK Catering LLC dba Floppers Food New Orleans District Office CGMP Regulation for Foods/Adulterated Not Issued *
01/06/2012 Wagner Provisions Co., Inc New Jersey District Office Acidified Foods/Acid Canned Food Regulation/Adulterated/Misbranded 07/31/2012
01/05/2012 Triple D Orchards, Inc. Detroit District Office CGMP Regulation for Foods/Adulterated Not Issued *
01/04/2012 Flavors from Florida, Inc. Florida District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
01/04/2012 Gulfish LP San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 01/24/2013
01/04/2012 Norland, A Cooper Surgical Company Minneapolis District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated/Misbranded 09/19/2012
01/03/2012 Thoratec Corporation San Francisco District Office CGMP/QSR/Medical Device Reporting/Misbranded Not Issued *
01/03/2012 Herbal Extracts Plus, LLC Philadelphia District Office New Drug/Labeling/Misbranded 08/07/2012
01/02/2012 Homeneeds Samamish, Inc. Seattle District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *

-