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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
December 04, 2012 Sunbeam Products, Inc. Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 04, 2012 Energist Limited Center for Devices and Radiological Health CGMP/QSR/Medical Device Reporting/Adulterated/Misbranded January 08, 2015
December 03, 2012 Alcon LenSx, Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated May 22, 2014
November 30, 2012 Sales USA, Inc Dallas District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions September 30, 2013
November 29, 2012 B&A Seafood Philadelphia District Office CGMP for Foods/Adulterated April 22, 2016
November 29, 2012 Mindray DS USA, Inc. d.b.a. Mindray North America New Jersey District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
November 29, 2012 Salem Hospital IRB Center for Drug Evaluation and Research Institutional Review Board (IRB) April 25, 2014
November 29, 2012 Trillium Farms LLC Cincinnati District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
November 29, 2012 Laser Energetics, Inc. Center for Devices and Radiological Health Electronic Product Radiation Control Not Issued *
November 28, 2012 Solta Medical, Inc. Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization Not Issued *
November 28, 2012 Seapak O.C.I. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions January 24, 2013
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 28, 2012 Golden Gate Soy Food, Inc. San Francisco District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 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 27, 2012 Parks Medical Electronics, Inc. Seattle District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
November 26, 2012 Sometech Incorporated Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
November 26, 2012 Avis Dairy San Francisco District Office Illegal Drug Residue Not Issued *
November 23, 2012 Seafood Supply Company, LP Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions September 16, 2014
November 23, 2012 Massimo's Dallas, Inc. Dallas District Office CGMP for Foods/Adulterated August 04, 2014
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 21, 2012 North Fish Co Ltd Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/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 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 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 Sharkco Seafood International L.L.C. New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions May 01, 2013
November 20, 2012 Performance Products Inc Kansas City District Office CGMP/Finished Pharmaceuticals/Animal Drugs/Misbranded July 16, 2013
November 19, 2012 Emu Products and Management, Inc. (EPMI) Dallas District Office New Drug/Misbranded Not Issued *
November 19, 2012 All American Trading Of Houston Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
November 19, 2012 Jing Sheng Company Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions/Misbranded Not Issued *
November 19, 2012 Medart A/S Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
November 19, 2012 Ipromo Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded January 18, 2013
November 19, 2012 TH Mello and Sons Dairy San Francisco District Office Illegal Drug Residue Not Issued *
November 19, 2012 Flanes Lymar San Juan District Office CGMP for Foods/Adulterated August 12, 2015
November 19, 2012 Jroll LLC dba Sushi On The Roll Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 19, 2012 InControl Medical, LLC Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated January 27, 2014
November 16, 2012 Sterling USA Neutraceutical Lab, LLC Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
November 16, 2012 Derek and Constance Lee Corporation (d.b.a. Great River Food) San Francisco District Office CGMP for Foods/Adulterated April 08, 2014
November 16, 2012 Don Selph Dallas District Office Illegal Drug Residue Not Issued *
November 16, 2012 Hulsbosch Dairy Farm Detroit District Office Illegal Drug Residue July 19, 2013
November 15, 2012 Martin Preferred Foods, L.P. Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 15, 2012 Fisherman's Market Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
November 15, 2012 Kamawi, Inc. Baltimore District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *
November 15, 2012 CASMED International, Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
November 15, 2012 Health Technology Inc. Atlanta District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
November 15, 2012 Manuel Gaspar & Son Dairy San Francisco District Office Illegal Drug Residue Not Issued *
November 14, 2012 AloeScience Labs, Inc. Dallas District Office CGMP Regulations For Dietary Supplements/Adulterated Not Issued *

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