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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
October 22, 2012 I Shay Cosmetics Inc Los Angeles District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
October 22, 2012 Health Breakthroughs International, LLC Seattle District Office Internet Marketing of Unapproved and Misbranded Drugs Not Issued *
October 22, 2012 Andersen America, Inc. San Francisco District Office CGMP for Foods/Seafood HACCP/Adulterated January 28, 2014
October 22, 2012 Alere San Diego, Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 22, 2012 NeuroMed Devices, Inc. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated/Misbranded Not Issued *
October 19, 2012 RTI Biologics, Inc. Florida District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) October 25, 2013
October 19, 2012 Young Ocean, Inc Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
October 19, 2012 www.tobaccoandcigarettes.net Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
October 19, 2012 Ipswich Shellfish Co., Inc. New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions January 29, 2013
October 18, 2012 Mushroom Wisdom, Inc. New Jersey District Office Unapproved and Misbranded New Drugs Not Issued *
October 18, 2012 Quanta Systems, S.p.A. Center for Devices and Radiological Health Medical Device Reporting/Adulterated/Misbranded Not Issued *
October 17, 2012 Pacheco & Fagundes Dairy San Francisco District Office Illegal Drug Residue Not Issued *
October 17, 2012 B & H Foods Inc Atlanta District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
October 17, 2012 Greencore USA, LLC New England District Office CGMP for Foods/Seafood HACCP/Adulterated April 05, 2013
October 16, 2012 Advanced Nutritional Technology Inc. San Francisco District Office CGMP/Dietary Supplement/Misbranding Not Issued *
October 16, 2012 Gomes Dairy San Francisco District Office Illegal Drug Residue Not Issued *
October 16, 2012 Hana Gourmet, Inc. dba Beyond Gourmet Dallas District Office Seafood HACCP/Adulterated August 13, 2013
October 16, 2012 Superfish S.A. Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
October 16, 2012 Nexera Medical, Inc. Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 16, 2012 Quincy Bioscience Manufacturing Inc. Minneapolis District Office Unapproved and Misbranded New Drugs Not Issued *
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 December 10, 2014
October 15, 2012 Gutman Brothers, LTD Philadelphia District Office Illegal Drug Residue April 15, 2013
October 12, 2012 Global Medical Holdings LLC Kansas City District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 12, 2012 www.clovecigarettesonline.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 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 11, 2012 Atrium Medical Corporation New England District Office CGMP/QSR/Medical Devices/Adulterated 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 Primus Medical LLC Cincinnati District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
October 10, 2012 Garlic Rx Cincinnati District Office New Drug/Labeling/Misbranded 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 Nissei Precision Instruments (Suzhou) Co., Ltd Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded 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 09, 2012 MEDDEV USA, INC. Dallas District Office Medical Devices/Adulterated/Quality System Regulation (QSR) Not Issued *
October 09, 2012 Medical Device Resource Corp San Francisco District Office Premarket Approval/Misbranded/Adulterated Not Issued *
October 09, 2012 SMT-Schilling Metalltechnik GmbH Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded July 16, 2015
October 09, 2012 Stat Rx USA Atlanta District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
October 09, 2012 Country Fresh Orlando, LLC Florida District Office Labeling/False & Misleading Claims/Misbranded July 11, 2013
October 05, 2012 Wholistic Herbs, Inc. Dallas District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
October 05, 2012 Food for Health International, LLC Denver District Office CGMP For Manufacturing, Packaging, Labeling, or Holding for Dietary Supplements/Adulterated January 13, 2014
October 05, 2012 Hiossen Inc. Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated November 19, 2013
October 05, 2012 Avon Products, Inc. (U.S. Headquarters) Center for Food Safety and Applied Nutrition New Drug/Misbranded Not Issued *
October 05, 2012 Xiantao Rayxin Medical Products Co. Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 05, 2012 Bioque Technology Center for Food Safety and Applied Nutrition New Drug Application [NDA] Not Issued *
October 05, 2012 Tri State Agri Services, LLC Dallas District Office CGMP for Licensed Medicated Feeds/Adulterated Not Issued *
October 04, 2012 Raw Deal, Inc New Jersey District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *

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