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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
July 03, 2012 Center for the Improvement of Human Functioning International, Inc. IRB Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *
July 03, 2012 New Rich City Co. Philadelphia District Office CGMP for Foods/Adulterated Not Issued *
June 29, 2012 RI. MOS S.R.L. Center for Devices and Radiological Health Adulterated Device Not Issued *
June 29, 2012 Siemens Healthcare Diagnostics, Inc. Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated January 28, 2013
June 29, 2012 Karl Bergman Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
June 28, 2012 Prismic Light International New Orleans District Office CGMP for Dietary Supplements/Adulterated/Misbranded Not Issued *
June 28, 2012 Rol-rom Foods New Jersey District Office Labeling/False & Misleading Claims/Misbranded August 22, 2014
June 28, 2012 Apia Enterprise Inc Los Angeles District Office Medical Device Reporting/Misbranded Not Issued *
June 28, 2012 McGovern Farm, Inc New England District Office Illegal Drug Residue Not Issued *
June 27, 2012 Dongguan Yongrong Plastic Products Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
June 27, 2012 Guangdong Baihe Medical Technology Co., Ltd Center for Devices and Radiological Health Adulterated Device July 23, 2013
June 27, 2012 HPC Foods, Ltd. San Francisco District Office Seafood HACCP/Adulterated Not Issued *
June 27, 2012 The Maschhoffs, LLC Chicago District Office Illegal Drug Residue Not Issued *
June 27, 2012 John Malcore Livestock LLC Minneapolis District Office Illegal Drug Residue March 26, 2013
June 26, 2012 Mexican Products & Spice Company Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
June 26, 2012 Alistrol Health Seattle District Office New Drug/Labeling/False & Misleading Claims/Misbranded Not Issued *
June 25, 2012 LAPBANDVIP.com Center for Devices and Radiological Health Medical Device/Misbranded Not Issued *
June 25, 2012 CigarWebService Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
June 22, 2012 Dutch Cowboy Dairy Denver District Office Illegal Drug Residue Not Issued *
June 21, 2012 Taiyo Seafood Boston Inc. New England District Office Seafood HACCP/Adulterated June 13, 2013
June 20, 2012 Gordon Food Company, Inc. Nashville District Office CGMP for Foods/Adulterated Not Issued *
June 20, 2012 Riverfront Egg Robbers Inc. Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions November 07, 2014
June 20, 2012 Hemofarm A.D. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated April 05, 2016
June 20, 2012 Ercros S.A. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated March 15, 2016
June 19, 2012 Grimm Scientific Industries Cincinnati District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded Not Issued *
June 19, 2012 ABCO Laboratories, Inc. San Francisco District Office Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded Not Issued *
June 18, 2012 Lone Star Calf Ranch, LP Dallas District Office Illegal Drug Residue Not Issued *
June 18, 2012 Foshan R. Poon Medical Products Co., Ltd. Center for Devices and Radiological Health Adulterated Device/Misbranded April 01, 2015
June 18, 2012 Oklahoma Respiratory Care, Inc. Dallas District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
June 18, 2012 Hai Nam Co., Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
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 Family Beginnings, PC Detroit District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products December 15, 2012
June 15, 2012 www.cigarettesbuyonline.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded August 15, 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.buycheaptobacco.net Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded June 15, 2012
June 15, 2012 Shamrock Medical Solutions Group LLC Cincinnati District Office CGMP for Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
June 14, 2012 Covidien LP New England District Office CGMP/QSR/Medical Devices/Adulterated April 21, 2013
June 14, 2012 Pinook-USA Florida District Office Medical Device/Adulterated/Misbranded Not Issued *
June 14, 2012 American· Optisurgical Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
June 14, 2012 Acclarent, Inc. San Francisco District Office CGMP/QSR/Medical Devices/Adulterated January 22, 2014
June 14, 2012 Metro Produce Distributors, Inc. Minneapolis District Office Juice/HACCP/Adulterated October 23, 2014
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 F Care Systems USA Florida District Office Medical Device Reporting/Misbranded/Adulterated Not Issued *
June 12, 2012 International Specialty Supply Holding, Inc. Nashville District Office Food/Insanitary Conditions/Adulterated Not Issued *
June 12, 2012 King Ransom Farm LLC New York District Office Illegal Drug Residue Not Issued *
June 12, 2012 Set-N-Me-Free Aloe Vera Co. Seattle District Office New Drug/Labeling/False & Misleading Claims/Misbranded Not Issued *
June 11, 2012 Oertel Medical GmbH Center for Devices and Radiological Health Adulterated Device Not Issued *
June 11, 2012 Cal Valls Center for Food Safety and Applied Nutrition Misbranding/Labeling Violation of Acidified Foods August 24, 2012
June 11, 2012 Zhucheng Haotian Pharm Co., Ltd. Center for Drug Evaluation and Research Failure to Register and List Not Issued *
June 11, 2012 Beekley Corporation New England District Office CGMP/QSR/Medical Devices/Adulterated June 23, 2015

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