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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
10/22/2012 Sugih Instrumendo Abadi, PT. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
10/22/2012 Andersen America, Inc. San Francisco District Office CGMP for Foods/Seafood HACCP/Adulterated 01/28/2014
10/22/2012 I Shay Cosmetics Inc Los Angeles District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
10/22/2012 NeuroMed Devices, Inc. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated/Misbranded Not Issued *
10/22/2012 Alere San Diego, Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
10/19/2012 RTI Biologics, Inc. Florida District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) 10/25/2013
10/19/2012 Ipswich Shellfish Co., Inc. New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 01/29/2013
10/19/2012 www.tobaccoandcigarettes.net Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
10/19/2012 Young Ocean, Inc Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
10/18/2012 Mushroom Wisdom, Inc. New Jersey District Office Unapproved and Misbranded New Drugs Not Issued *
10/18/2012 Quanta Systems, S.p.A. Center for Devices and Radiological Health Medical Device Reporting/Adulterated/Misbranded Not Issued *
10/17/2012 B & H Foods Inc Atlanta District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
10/17/2012 Pacheco & Fagundes Dairy San Francisco District Office Illegal Drug Residue Not Issued *
10/17/2012 Greencore USA, LLC New England District Office CGMP for Foods/Seafood HACCP/Adulterated 04/05/2013
10/16/2012 Nexera Medical, Inc. Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
10/16/2012 Advanced Nutritional Technology Inc. San Francisco District Office CGMP/Dietary Supplement/Misbranding Not Issued *
10/16/2012 Quincy Bioscience Manufacturing Inc. Minneapolis District Office Unapproved and Misbranded New Drugs Not Issued *
10/16/2012 Superfish S.A. Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
10/16/2012 Gomes Dairy San Francisco District Office Illegal Drug Residue Not Issued *
10/16/2012 Hana Gourmet, Inc. dba Beyond Gourmet Dallas District Office Seafood HACCP/Adulterated 08/13/2013
10/15/2012 Alby's Seafood, Inc. Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
10/15/2012 BioNeurix Corporation Los Angeles District Office Dietary Supplement/Labeling/Misbranded Not Issued *
10/15/2012 Gold Coast United, Inc. Baltimore District Office CGMP Regulation for Foods/Adulterated 03/22/2013
10/15/2012 Gutman Brothers, LTD Philadelphia District Office Illegal Drug Residue 04/15/2013
10/15/2012 Ortho Molecular Products Inc Minneapolis District Office New Drug/Labeling/Misbranded 12/10/2014
10/12/2012 Global Medical Holdings LLC Kansas City District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
10/12/2012 www.clovecigarettesonline.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
10/11/2012 Skin Biology, Inc. Seattle District Office New Drug/Labeling/False & Misleading Claims Not Issued *
10/11/2012 De Jong Dairy Seattle District Office Illegal Drug Residue Not Issued *
10/11/2012 Atrium Medical Corporation New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
10/11/2012 Finca Cojobas, Inc. San Juan District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
10/10/2012 Nissei Precision Instruments (Suzhou) Co., Ltd Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
10/10/2012 Balin, Martin S., MD, PhD Chicago District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) 04/23/2013
10/10/2012 Primus Medical LLC Cincinnati District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
10/10/2012 PC Tan Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
10/10/2012 Garlic Rx Cincinnati District Office New Drug/Labeling/Misbranded Not Issued *
10/10/2012 Zian Medical, LLC Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
10/09/2012 MEDDEV USA, INC. Dallas District Office Medical Devices/Adulterated/Quality System Regulation (QSR) Not Issued *
10/09/2012 Medical Device Resource Corp San Francisco District Office Premarket Approval/Misbranded/Adulterated Not Issued *
10/09/2012 Country Fresh Orlando, LLC Florida District Office Labeling/False & Misleading Claims/Misbranded 07/11/2013
10/09/2012 Stat Rx USA Atlanta District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
10/09/2012 SMT-Schilling Metalltechnik GmbH Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded 07/16/2015
10/05/2012 Food for Health International, LLC Denver District Office CGMP For Manufacturing, Packaging, Labeling, or Holding for Dietary Supplements/Adulterated 01/13/2014
10/05/2012 Hiossen Inc. Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated 11/19/2013
10/05/2012 Wholistic Herbs, Inc. Dallas District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
10/05/2012 Tri State Agri Services, LLC Dallas District Office CGMP for Licensed Medicated Feeds/Adulterated Not Issued *
10/05/2012 Bioque Technology Center for Food Safety and Applied Nutrition New Drug Application [NDA] Not Issued *
10/05/2012 Xiantao Rayxin Medical Products Co. Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
10/05/2012 Avon Products, Inc. (U.S. Headquarters) Center for Food Safety and Applied Nutrition New Drug/Misbranded Not Issued *
10/04/2012 Raw Deal, Inc New Jersey District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *

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