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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 LeCaptain, Mark D. Minneapolis District Office Illegal Drug Residue February 27, 2012
January 13, 2012 Blount Seafood Corporation New England District Office Seafood HACCP/CGMP for Foods/Adulterated May 31, 2013
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 12, 2012 Augusta Medical Systems, LLC Atlanta District Office CGMP/QSR/Medical Devices/Adulterated 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 Agora Publishing Inc Baltimore District Office New Drug/Labeling/Misbranded Not Issued *
January 10, 2012 Progressive Medical Inc Kansas City District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded August 03, 2012
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 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 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 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 Norland, A Cooper Surgical Company Minneapolis District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated/Misbranded September 19, 2012
January 04, 2012 Gulfish LP San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions January 24, 2013
January 03, 2012 Herbal Extracts Plus, LLC Philadelphia District Office New Drug/Labeling/Misbranded August 07, 2012
January 03, 2012 Thoratec Corporation San Francisco District Office CGMP/QSR/Medical Device Reporting/Misbranded Not Issued *
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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