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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
07/05/2012 Kasa's Food Distributing Co. Philadelphia District Office Food Labeling/Misbranded 12/11/2012
07/03/2012 Center for the Improvement of Human Functioning International, Inc. IRB Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *
07/03/2012 New Rich City Co. Philadelphia District Office CGMP for Foods/Adulterated Not Issued *
06/29/2012 Karl Bergman Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
06/29/2012 RI. MOS S.R.L. Center for Devices and Radiological Health Adulterated Device Not Issued *
06/29/2012 Siemens Healthcare Diagnostics, Inc. Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated 01/28/2013
06/28/2012 Apia Enterprise Inc Los Angeles District Office Medical Device Reporting/Misbranded Not Issued *
06/28/2012 Rol-rom Foods New Jersey District Office Labeling/False & Misleading Claims/Misbranded 08/22/2014
06/28/2012 McGovern Farm, Inc New England District Office Illegal Drug Residue Not Issued *
06/28/2012 Prismic Light International New Orleans District Office CGMP for Dietary Supplements/Adulterated/Misbranded Not Issued *
06/27/2012 HPC Foods, Ltd. San Francisco District Office Seafood HACCP/Adulterated Not Issued *
06/27/2012 John Malcore Livestock LLC Minneapolis District Office Illegal Drug Residue 03/26/2013
06/27/2012 Guangdong Baihe Medical Technology Co., Ltd Center for Devices and Radiological Health Adulterated Device 07/23/2013
06/27/2012 The Maschhoffs, LLC Chicago District Office Illegal Drug Residue Not Issued *
06/27/2012 Dongguan Yongrong Plastic Products Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
06/26/2012 Alistrol Health Seattle District Office New Drug/Labeling/False & Misleading Claims/Misbranded Not Issued *
06/26/2012 Mexican Products & Spice Company Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
06/25/2012 CigarWebService Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
06/25/2012 LAPBANDVIP.com Center for Devices and Radiological Health Medical Device/Misbranded Not Issued *
06/22/2012 Dutch Cowboy Dairy Denver District Office Illegal Drug Residue Not Issued *
06/21/2012 Taiyo Seafood Boston Inc. New England District Office Seafood HACCP/Adulterated 06/13/2013
06/20/2012 Ercros S.A. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated 03/15/2016
06/20/2012 Gordon Food Company, Inc. New Orleans District Office CGMP for Foods/Adulterated Not Issued *
06/20/2012 Riverfront Egg Robbers Inc. Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 11/07/2014
06/20/2012 Hemofarm A.D. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated 04/05/2016
06/19/2012 ABCO Laboratories, Inc. San Francisco District Office Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded Not Issued *
06/19/2012 Grimm Scientific Industries Cincinnati District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded Not Issued *
06/18/2012 Lone Star Calf Ranch, LP Dallas District Office Illegal Drug Residue Not Issued *
06/18/2012 Foshan R. Poon Medical Products Co., Ltd. Center for Devices and Radiological Health Adulterated Device/Misbranded 04/01/2015
06/18/2012 Oklahoma Respiratory Care, Inc. Dallas District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
06/18/2012 Hai Nam Co., Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
06/15/2012 www.buycheaptobacco.net Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 06/15/2012
06/15/2012 www.buycheaptobacco.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 07/20/2012
06/15/2012 Shamrock Medical Solutions Group LLC Cincinnati District Office CGMP for Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
06/15/2012 www.buytobacco.net Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 07/20/2012
06/15/2012 www.cigarettesbuyonline.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 08/15/2012
06/15/2012 Family Beginnings, PC Detroit District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products 12/15/2012
06/14/2012 American· Optisurgical Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
06/14/2012 Pinook-USA Florida District Office Medical Device/Adulterated/Misbranded Not Issued *
06/14/2012 Acclarent, Inc. San Francisco District Office CGMP/QSR/Medical Devices/Adulterated 01/22/2014
06/14/2012 Covidien LP New England District Office CGMP/QSR/Medical Devices/Adulterated 04/21/2013
06/14/2012 Metro Produce Distributors, Inc. Minneapolis District Office Juice/HACCP/Adulterated 10/23/2014
06/13/2012 Compania Internacional de Comercio, S.A. de C.V. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
06/12/2012 Set-N-Me-Free Aloe Vera Co. Seattle District Office New Drug/Labeling/False & Misleading Claims/Misbranded Not Issued *
06/12/2012 F Care Systems USA Florida District Office Medical Device Reporting/Misbranded/Adulterated Not Issued *
06/12/2012 International Specialty Supply Holding, Inc. New Orleans District Office Food/Insanitary Conditions/Adulterated Not Issued *
06/12/2012 King Ransom Farm LLC New York District Office Illegal Drug Residue Not Issued *
06/11/2012 Brouillette Farm, Inc. New England District Office Illegal Drug Residue Not Issued *
06/11/2012 Oertel Medical GmbH Center for Devices and Radiological Health Adulterated Device Not Issued *
06/11/2012 Cal Valls Center for Food Safety and Applied Nutrition Misbranding/Labeling Violation of Acidified Foods 08/24/2012

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