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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
March 13, 2012 IntelliCell Biosciences, Inc. Center for Biologics Evaluation and Research Current Good Manufacturing Practice(CGMP)/Current Good Tissue Practice(CGTP) Not Issued *
March 13, 2012 A&M Farms San Francisco District Office Illegal Drug Residue Not Issued *
March 12, 2012 Mysnus AB Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded May 21, 2012
March 09, 2012 Double Aught Dairy Denver District Office Illegal Drug Residue Not Issued *
March 09, 2012 Sebastian Joe's Ice Cream Commissary Minneapolis District Office Food Labeling Misbranded August 26, 2014
March 09, 2012 Pax-All Manufacturing Inc. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
March 09, 2012 Laboratorios Jaloma S.A. de C.V. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated July 01, 2014
March 09, 2012 Farma Quimia S.A. de C.V. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
March 09, 2012 Cosmed S.R.L. Center for Devices and Radiological Health CGMP for Medical Devices/QSR/Medical Device Reporting/Misbranded Not Issued *
March 08, 2012 Warner Chilcott Company, LLC San Juan District Office CGMP Regulations for Finished Pharmaceuticals/Adulterated June 07, 2013
March 07, 2012 Nobilus Ent Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
March 07, 2012 Heartway Medical Products Co., Ltd. Center for Devices and Radiological Health CGMP for Medical Devices/QSR/Medical Device Reporting/Adulterated Not Issued *
March 07, 2012 Fong Kee Tofu Company, Inc. San Francisco District Office CGMP Regulation for Foods/Misbranded Not Issued *
March 07, 2012 Modern Products, Inc. Minneapolis District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated September 05, 2013
March 07, 2012 Osypka Medical GmbH Center for Devices and Radiological Health CGMP for Medical Devices/QSR/Medical Device Reporting/Adulterated/Misbranded Not Issued *
March 07, 2012 Staples, Incorporated San Francisco District Office CGMP for Foods/Adulterated July 27, 2012
March 07, 2012 Zhong Shun Inc. Los Angeles District Office Seafood HACCP/Adulterated Not Issued *
March 06, 2012 Box Canyon Dairy Seattle District Office Illegal Drug Residue Not Issued *
March 06, 2012 SystemsOne, LLC Florida District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded Not Issued *
March 06, 2012 Griebel Dairy Farms Philadelphia District Office Illegal Drug Residue January 11, 2013



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