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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
March 29, 2012 Spaletta Ranch San Francisco District Office Illegal Drug Residue Not Issued *
March 29, 2012 American Fish & Seafood Co. San Francisco District Office Seafood HACCP/Adulterated Not Issued *
March 29, 2012 Concept Asia Food Service LLC Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
March 28, 2012 Health One Pharmaceuticals Inc Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
March 28, 2012 Chinese Peptide Company Center for Drug Evaluation and Research Failure to Register and List May 15, 2012
March 27, 2012 ThyssenKrupp Access Manufacturing, LLC Chicago District Office CGMP/QSR/Medical Devices/Adulterated November 29, 2012
March 27, 2012 H & H Wholesale Services, Inc. Detroit District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
March 27, 2012 Christian Hospital Northeast-Northwest Center for Biologics Evaluation and Research IRB May 07, 2012
March 27, 2012 Shanghai Shunlong Physical Therapy Equipment Co. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
March 27, 2012 Ogenix Corporation Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated September 11, 2012
March 27, 2012 UNAM, Facultad De Estudios Superiores Cuautitlan Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
March 27, 2012 River Ranch Fresh Foods, LLC San Francisco District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *
March 26, 2012 Kentron Health Care, Inc. New Orleans District Office Medical Device Reporting/Misbranded October 18, 2012
March 26, 2012 Sullivan Lane Farm Philadelphia District Office Illegal Drug Residue November 21, 2013
March 26, 2012 Korea Pharma Company Ltd Center for Drug Evaluation and Research Failure to Register and List Not Issued *
March 26, 2012 SEI Pharmaceuticals, Inc. Florida District Office CGMP For Manufacturing, Packaging, Labeling, or Holding for Dietary Supplements/Adulterated Not Issued *
March 26, 2012 Custom Seafood Services Inc. Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
March 23, 2012 Meherrin Agricultural & Chemical Co. Atlanta District Office CGMP for Foods/Adulterated Not Issued *
March 23, 2012 Plenus Group Inc. New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
March 23, 2012 cigarettesbuyer.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded May 24, 2012



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