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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

2012 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
June 20, 2012 Gordon Food Company, Inc. Nashville District Office CGMP for Foods/Adulterated Not Issued *
June 19, 2012 ABCO Laboratories, Inc. San Francisco District Office Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded Not Issued *
June 19, 2012 Grimm Scientific Industries Cincinnati District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded Not Issued *
June 18, 2012 Oklahoma Respiratory Care, Inc. Dallas District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
June 18, 2012 Lone Star Calf Ranch, LP Dallas District Office Illegal Drug Residue Not Issued *
June 18, 2012 Hai Nam Co., Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
June 18, 2012 Foshan R. Poon Medical Products Co., Ltd. Center for Devices and Radiological Health Adulterated Device/Misbranding Not Issued *
June 15, 2012 Family Beginnings, PC Detroit District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products December 15, 2012
June 15, 2012 Shamrock Medical Solutions Group LLC Cincinnati District Office CGMP for Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
June 15, 2012 www.buycheaptobacco.net Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded June 15, 2012
June 15, 2012 www.buycheaptobacco.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded July 20, 2012
June 15, 2012 www.buytobacco.net Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded July 20, 2012
June 15, 2012 www.cigarettesbuyonline.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded August 15, 2012
June 14, 2012 Metro Produce Distributors, Inc. Minneapolis District Office Juice/HACCP/Adulterated Not Issued *
June 14, 2012 Acclarent, Inc. San Francisco District Office CGMP/QSR/Medical Devices/Adulterated January 22, 2014
June 14, 2012 American· Optisurgical Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
June 14, 2012 Pinook-USA Florida District Office Medical Device/Adulterated/Misbranded Not Issued *
June 14, 2012 Covidien LP New England District Office CGMP/QSR/Medical Devices/Adulterated April 21, 2013
June 13, 2012 Compania Internacional de Comercio, S.A. de C.V. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
June 12, 2012 Set-N-Me-Free Aloe Vera Co. Seattle District Office New Drug/Labeling/False & Misleading Claims/Misbranded Not Issued *



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