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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
December 07, 2012 Basic Organics, Inc. Cincinnati District Office CGMP Regulations For Dietary Supplements/Adulterated August 23, 2013
December 07, 2012 Gonsalves Ranch San Francisco District Office Illegal Drug Residue 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 06, 2012 The Judge Rotenberg Educational Center New England District Office Device/Adulterated Not Issued *
December 06, 2012 www.kretekstore.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded March 18, 2014
December 05, 2012 O Guest Ranch Maui LLC/dba Surfing Goat Dairy San Francisco District Office CGMP for Foods/Adulterated August 01, 2013
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 Energist Limited Center for Devices and Radiological Health CGMP/QSR/Medical Device Reporting/Adulterated/Misbranded Not Issued *
December 04, 2012 Sunbeam Products, Inc. Florida District Office CGMP/QSR/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 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 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 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 B&A Seafood Philadelphia District Office CGMP for Foods/Adulterated 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 Solta Medical, Inc. Center for Devices and Radiological Health Medical Devices/Institutional Review Board (IRB) Not Issued *



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