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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
September 24, 2012 Celltex Therapeutics Corporation Center for Biologics Evaluation and Research Human Cells, Tissues & Cellular Products Not Issued *
September 21, 2012 Andes Natural Center for Food Safety and Applied Nutrition New Drug Application [NDA] Not Issued *
September 21, 2012 Memorial Hospital Of South Bend, IRB Center for Drug Evaluation and Research Institutional Review Board (IRB) April 28, 2014
September 21, 2012 Sunset Dairy Philadelphia District Office Illegal Drug Residue Not Issued *
September 21, 2012 Janson-Beckett Center for Food Safety and Applied Nutrition New Drug Application [NDA] Not Issued *
September 21, 2012 Canadadrugs Center for Drug Evaluation and Research Unapproved and Misbranded New Drugs Not Issued *
September 19, 2012 Southwind Foods LLC dba Great American Seafood Imports Co. Los Angeles District Office Labeling/Misbranded Not Issued *
September 19, 2012 Zimmer Manufacturing B.V. San Juan District Office CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation Not Issued *
September 19, 2012 Epimed International, Inc. New York District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
September 19, 2012 Create-A-Pack Foods, Inc. Minneapolis District Office CGMP/Acidified Foods/Adulterated Not Issued *
September 18, 2012 Sun Boricua, Inc. San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions June 07, 2013
September 18, 2012 Fayus, Inc. dba Yusol International Foods San Francisco District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
September 18, 2012 EyeScience Labs, L.L.C. Cincinnati District Office Promotional Claims False & Misleading/New Drugs Not Issued *
September 18, 2012 Hopkins, E Frank Co., Inc. Philadelphia District Office CGMP for Foods/Adulterated March 19, 2013
September 18, 2012 Pronet/Eyal Bar Oz Center for Drug Evaluation and Research Unapproved and Misbranded New Drugs Not Issued *
September 18, 2012 Arkadiy Kisin/White Forest Solutions Center for Drug Evaluation and Research Unapproved and Misbranded New Drugs Not Issued *
September 18, 2012 Grindstone Neck of Maine, LLC New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions October 28, 2014
September 14, 2012 Oregon Aesthetic Technologies, Inc. Seattle District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
September 14, 2012 www.cigarettes-com.net Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
September 14, 2012 Nunes Brothers Dairy Seattle District Office Illegal Drug Residue Not Issued *



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