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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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2012 Warning Letters

Posted on October 23, 2012

Letter Issue Date Company Name Issuing Office Subject Close Out Date
October 16, 2012 Gomes Dairy San Francisco District Office Illegal Drug Residue Not Issued *
October 16, 2012 Nexera Medical, Inc. Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 15, 2012 Gutman Brothers, LTD Philadelphia District Office Illegal Drug Residue April 15, 2013
October 15, 2012 Alby's Seafood, Inc. Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
October 15, 2012 BioNeurix Corporation Los Angeles District Office Dietary Supplement/Labeling/Misbranded Not Issued *
October 15, 2012 Gold Coast United, Inc. Baltimore District Office CGMP Regulation for Foods/Adulterated March 22, 2013
October 15, 2012 Ortho Molecular Products Inc Minneapolis District Office New Drug/Labeling/Misbranded Not Issued *
October 12, 2012 www.clovecigarettesonline.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
October 12, 2012 Global Medical Holdings LLC Kansas City District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 11, 2012 Atrium Medical Corporation New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 11, 2012 Finca Cojobas, Inc. San Juan District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
October 11, 2012 Skin Biology, Inc. Seattle District Office New Drug/Labeling/False & Misleading Claims Not Issued *
October 11, 2012 De Jong Dairy Seattle District Office Illegal Drug Residue Not Issued *
October 10, 2012 PC Tan Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
October 10, 2012 Zian Medical, LLC Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
October 10, 2012 Balin, Martin S., MD, PhD Chicago District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) April 23, 2013
October 10, 2012 Garlic Rx Cincinnati District Office New Drug/Labeling/Misbranded Not Issued *
October 10, 2012 Primus Medical LLC Cincinnati District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
October 10, 2012 Nissei Precision Instruments (Suzhou) Co., Ltd Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
October 09, 2012 Country Fresh Orlando, LLC Florida District Office Labeling/False & Misleading Claims/Misbranded Not Issued *


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