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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2012 Warning Letters

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

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