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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
12/04/2012 Sunbeam Products, Inc. Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
12/04/2012 Energist Limited Center for Devices and Radiological Health CGMP/QSR/Medical Device Reporting/Adulterated/Misbranded 01/08/2015
12/03/2012 Alcon LenSx, Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated 05/22/2014
11/30/2012 Sales USA, Inc Dallas District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 09/30/2013
11/29/2012 B&A Seafood Philadelphia District Office CGMP for Foods/Adulterated 04/22/2016
11/29/2012 Mindray DS USA, Inc. d.b.a. Mindray North America New Jersey District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
11/29/2012 Salem Hospital IRB Center for Drug Evaluation and Research Institutional Review Board (IRB) 04/25/2014
11/29/2012 Trillium Farms LLC Cincinnati District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
11/29/2012 Laser Energetics, Inc. Center for Devices and Radiological Health Electronic Product Radiation Control Not Issued *
11/28/2012 Solta Medical, Inc. Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization Not Issued *
11/28/2012 Seapak O.C.I. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 01/24/2013
11/28/2012 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 *
11/28/2012 Golden Gate Soy Food, Inc. San Francisco District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
11/27/2012 Pallas S.A. Confections Center for Food Safety and Applied Nutrition CGMP Food Labeling/Misbranded/Adulterated Not Issued *
11/27/2012 Koon Cheong Lung Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
11/27/2012 Meerland Dairy Llc Cincinnati District Office Illegal Drug Residue Not Issued *
11/27/2012 Parks Medical Electronics, Inc. Seattle District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
11/26/2012 Sometech Incorporated Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
11/26/2012 Avis Dairy San Francisco District Office Illegal Drug Residue Not Issued *
11/23/2012 Seafood Supply Company, LP Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 09/16/2014
11/23/2012 Massimo's Dallas, Inc. Dallas District Office CGMP for Foods/Adulterated 08/04/2014
11/23/2012 SHANGHAI RUIKE SPORTS GOODS CO., LTD. Center for Devices and Radiological Health Quality System Regulation/Medical Device Reporting/Adulterated Not Issued *
11/21/2012 North Fish Co Ltd Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
11/21/2012 Sol Fish Traders Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
11/21/2012 Ocean Pier, Inc. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
11/21/2012 GC America, Inc. Chicago District Office Device/Adulterated Not Issued *
11/20/2012 Leisure Products, Inc. Nashville District Office Device/Adulterated Not Issued *
11/20/2012 Hawks Nuts, Inc. Florida District Office Low Acid Canned Food Regulation/Adulterated 05/02/2013
11/20/2012 Sharkco Seafood International L.L.C. New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 05/01/2013
11/20/2012 Performance Products Inc Kansas City District Office CGMP/Finished Pharmaceuticals/Animal Drugs/Misbranded 07/16/2013
11/19/2012 Emu Products and Management, Inc. (EPMI) Dallas District Office New Drug/Misbranded Not Issued *
11/19/2012 All American Trading Of Houston Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
11/19/2012 Jing Sheng Company Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions/Misbranded Not Issued *
11/19/2012 Medart A/S Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
11/19/2012 Ipromo Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 01/18/2013
11/19/2012 TH Mello and Sons Dairy San Francisco District Office Illegal Drug Residue Not Issued *
11/19/2012 Flanes Lymar San Juan District Office CGMP for Foods/Adulterated 08/12/2015
11/19/2012 Jroll LLC dba Sushi On The Roll Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
11/19/2012 InControl Medical, LLC Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated 01/27/2014
11/16/2012 Sterling USA Neutraceutical Lab, LLC Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
11/16/2012 Derek and Constance Lee Corporation (d.b.a. Great River Food) San Francisco District Office CGMP for Foods/Adulterated 04/08/2014
11/16/2012 Don Selph Dallas District Office Illegal Drug Residue Not Issued *
11/16/2012 Hulsbosch Dairy Farm Detroit District Office Illegal Drug Residue 07/19/2013
11/15/2012 Martin Preferred Foods, L.P. Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
11/15/2012 Fisherman's Market Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
11/15/2012 Kamawi, Inc. Baltimore District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *
11/15/2012 CASMED International, Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
11/15/2012 Health Technology Inc. Atlanta District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
11/15/2012 Manuel Gaspar & Son Dairy San Francisco District Office Illegal Drug Residue Not Issued *
11/14/2012 AloeScience Labs, Inc. Dallas District Office CGMP Regulations For Dietary Supplements/Adulterated Not Issued *

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