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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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2012 Warning Letters

Posted on July 24, 2012

Letter Issue Date Company Name Issuing Office Subject Close Out Date
July 09, 2012 Cutera Inc. Center for Devices and Radiological Health Device/Adulterated Not Issued *
July 06, 2012 Vincent Piazza, Jr. & Sons Seafood, Inc. New Orleans District Office CGMP for Foods/Adulterated Not Issued *
July 05, 2012 Kasa's Food Distributing Co. Philadelphia District Office Food Labeling/Misbranded December 11, 2012
July 05, 2012 Caseificio Sociale Manciano Center for Food Safety and Applied Nutrition CGMP for Food/Adulterated Not Issued *
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 Karl Bergman Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 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 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 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 Not Issued *
June 27, 2012 HPC Foods, Ltd. San Francisco District Office Seafood HACCP/Adulterated Not Issued *
June 27, 2012 Guangdong Baihe Medical Technology Co., Ltd Center for Devices and Radiological Health Adulterated Device 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 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 Alistrol Health Seattle District Office New Drug/Labeling/False & Misleading Claims/Misbranded Not Issued *
June 26, 2012 Mexican Products & Spice Company Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *


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