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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 Formulife, Inc.Purus Labs, Inc.d.b.a. Dark Cyde Supplements Dallas District Office Dietary Supplements/Food/New Drug/Adulterated/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 Blount Seafood Corporation New England District Office Seafood HACCP/CGMP for Foods/Adulterated May 31, 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 LeCaptain, Mark D. Minneapolis District Office Illegal Drug Residue February 27, 2012
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 12, 2012 Soring Medical Technology Florida 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 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



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