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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2013 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
June 06, 2013 S Serra Cheese Company Detroit District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
June 05, 2013 Automated Ophthalmics, Inc. Baltimore District Office CGMP/QSR/Medical Devices/Adulterated February 18, 2014
June 05, 2013 Henry A Frazer, Pharm D, Clinical Investigator Center for Drug Evaluation and Research Clinical Investigator Not Issued *
June 05, 2013 Baarda Farms Seattle District Office Illegal Drug Residue Not Issued *
June 04, 2013 Annasea International Hawaii, LLC San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
June 04, 2013 Cara Donna Provision Company New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions January 30, 2014
June 04, 2013 Techlem Medical Corporation Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
June 04, 2013 Changzhou Qianhong Bio-Pharma Co., Ltd Center for Drug Evaluation and Research Failure to Register and List July 09, 2013
June 03, 2013 www.alstobacco.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded November 07, 2013
June 03, 2013 Roest Family Dairy San Francisco District Office Illegal Drug Residue Not Issued *
May 31, 2013 Baxter Healthcare Corporation Atlanta District Office CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated Not Issued *
May 31, 2013 SpineNet Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 30, 2013 Amos Conley Farms Philadelphia District Office Illegal Drug Residue December 17, 2013
May 30, 2013 Kerber, Inc. Philadelphia District Office Labeling/False & Misleading Claims/Misbranded December 17, 2013
May 29, 2013 Bio-Botanica, Inc. New York District Office New Drug/Misbranded Not Issued *
May 28, 2013 Protano & Sons Inc. Florida District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
May 28, 2013 Ebewe Pharma Ges MBH Nfg KG Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
May 28, 2013 Hospira Healthcare India Pvt. Ltd. Center for Drug Evaluation and Research CGMP/Adulterated Not Issued *
May 28, 2013 RPG Life Sciences Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
May 24, 2013 ConvaTec Inc. New Jersey District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *



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