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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
November 28, 2012 Solta Medical, Inc. Center for Devices and Radiological Health Medical Devices/Institutional Review Board (IRB) Not Issued *
November 28, 2012 Tissue Bank International/The National Eye Bank Center New Orleans District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products(HCT/Ps) Not Issued *
November 27, 2012 Parks Medical Electronics, Inc. Seattle District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
November 27, 2012 Pallas S.A. Confections Center for Food Safety and Applied Nutrition CGMP Food Labeling/Misbranded/Adulterated Not Issued *
November 27, 2012 Koon Cheong Lung Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 27, 2012 Meerland Dairy Llc Cincinnati District Office Illegal Drug Residue Not Issued *
November 26, 2012 Avis Dairy San Francisco District Office New Animal Drug/Adulterated Not Issued *
November 26, 2012 Sometech Incorporated Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
November 23, 2012 Seafood Supply Company, LP Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 23, 2012 SHANGHAI RUIKE SPORTS GOODS CO., LTD. Center for Devices and Radiological Health Quality System Regulation/Medical Device Reporting/Adulterated Not Issued *
November 23, 2012 Massimo's Dallas, Inc. Dallas District Office CGMP for Foods/Adulterated Not Issued *
November 21, 2012 North Fish Co Ltd Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
November 21, 2012 Ocean Pier, Inc. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 21, 2012 GC America, Inc. Chicago District Office Device/Adulterated Not Issued *
November 21, 2012 Sol Fish Traders Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
November 20, 2012 Sharkco Seafood International L.L.C. New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions May 01, 2013
November 20, 2012 Leisure Products, Inc. Nashville District Office Device/Adulterated Not Issued *
November 20, 2012 Hawks Nuts, Inc. Florida District Office Low Acid Canned Food Regulation/Adulterated May 02, 2013
November 20, 2012 Performance Products Inc Kansas City District Office CGMP/Finished Pharmaceuticals/Animal Drugs/Misbranded July 16, 2013
November 19, 2012 Flanes Lymar San Juan District Office CGMP for Foods/Adulterated Not Issued *



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