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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
October 24, 2012 U.S.A Far Ocean Group LLC/Health & Beauty Group Inc. Los Angeles District Office Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded Not Issued *
October 24, 2012 ABH Nature's Products, Inc. New York District Office CGMP For Manufacturing, Packing, Labeling, or Holding for Dietary Supplements/Adulterated/Misbranded Not Issued *
October 23, 2012 Hail Merry, LLC Dallas District Office Food Labeling/False & Misleading/Misbranded Not Issued *
October 23, 2012 Finger Lakes Farmstead Cheese Company LLC New York District Office CGMP Regulation For Food/Adulterated Not Issued *
October 23, 2012 International Laboratories (Canada) Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
October 23, 2012 Westone Laboratories Incorporated Denver District Office CGMP/QSR/Medical Devices/Adulterated September 10, 2013
October 23, 2012 Phil Jon Farms Philadelphia District Office Illegal Drug Residue May 08, 2013
October 22, 2012 Alere San Diego, Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 22, 2012 Health Breakthroughs International, LLC Seattle District Office Internet Marketing of Unapproved and Misbranded Drugs 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 22, 2012 Andersen America, Inc. San Francisco District Office CGMP for Foods/Seafood HACCP/Adulterated January 28, 2014
October 22, 2012 Sugih Instrumendo Abadi, PT. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
October 22, 2012 I Shay Cosmetics Inc Los Angeles District Office CGMP/Finished Pharmaceuticals/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 Ipswich Shellfish Co., Inc. New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions January 29, 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 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 Greencore USA, LLC New England District Office CGMP for Foods/Seafood HACCP/Adulterated April 05, 2013



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