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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 January 08, 2013

Letter Issue Date Company Name Issuing Office Subject Close Out Date
December 06, 2012 www.kretekstore.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
December 06, 2012 The Judge Rotenberg Educational Center New England District Office Device/Adulterated Not Issued *
December 06, 2012 Axiobionics Detroit District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 06, 2012 www.kretekstore.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
December 05, 2012 O Guest Ranch Maui LLC/dba Surfing Goat Dairy San Francisco District Office CGMP for Foods/Adulterated Not Issued *
December 05, 2012 Tianjin Hanaco Xingda Medical Co., Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
December 04, 2012 USPlabs, LLC Dallas District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
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 Not Issued *
December 03, 2012 Alcon LenSx, Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
November 30, 2012 Sales USA, Inc Dallas District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 29, 2012 Salem Hospital IRB Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *
November 29, 2012 Trillium Farms LLC Cincinnati District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
November 29, 2012 B&A Seafood Philadelphia District Office CGMP for Foods/Adulterated Not Issued *
November 29, 2012 Laser Energetics, Inc. Center for Devices and Radiological Health Electronic Product Radiation Control Not Issued *
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 28, 2012 Solta Medical, Inc. Center for Devices and Radiological Health Medical Devices/Institutional Review Board (IRB) 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 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 *


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