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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

 
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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 Baarda Farms Seattle District Office Illegal Drug Residue 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 04, 2013 Cara Donna Provision Company New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions January 30, 2014
June 04, 2013 Changzhou Qianhong Bio-Pharma Co., Ltd Center for Drug Evaluation and Research Failure to Register and List July 09, 2013
June 04, 2013 Annasea International Hawaii, LLC San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
June 04, 2013 Techlem Medical Corporation Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
June 03, 2013 Roest Family Dairy San Francisco District Office Illegal Drug Residue Not Issued *
June 03, 2013 www.alstobacco.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded November 07, 2013
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 Ebewe Pharma Ges MBH Nfg KG Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated 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 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 Edwards Lifesciences, LLC Denver District Office CGMP/QSR/Medical Device Reporting/Adulterated Not Issued *



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