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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
January 18, 2012 Almased USA, Inc. Florida District Office Dietary Supplement/Labeling/False & Misleading Claims/Misbranded Not Issued *
January 18, 2012 LushLife Gardens New Jersey District Office Unsanitary Conditions/Adulterated April 09, 2013
January 17, 2012 Landshire, Inc Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions September 06, 2013
January 17, 2012 Creekside Springs LLC Cincinnati District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
January 17, 2012 Hillside Veal Philadelphia District Office Illegal Drug Residue November 21, 2013
January 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 *
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 Not Issued *
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 *



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