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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
06/05/2013 Baarda Farms Seattle District Office Illegal Drug Residue Not Issued *
06/05/2013 Automated Ophthalmics, Inc. Baltimore District Office CGMP/QSR/Medical Devices/Adulterated 02/18/2014
06/05/2013 Frazer, Henry A. Pharm D Center for Drug Evaluation and Research Clinical Investigator Not Issued *
06/04/2013 Cara Donna Provision Company New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 01/30/2014
06/04/2013 Changzhou Qianhong Bio-Pharma Co., Ltd Center for Drug Evaluation and Research Failure to Register and List 07/09/2013
06/04/2013 Annasea International Hawaii, LLC San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
06/04/2013 Techlem Medical Corporation Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
06/03/2013 Roest Family Dairy San Francisco District Office Illegal Drug Residue Not Issued *
06/03/2013 www.alstobacco.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 11/07/2013
05/31/2013 Baxter Healthcare Corporation Atlanta District Office CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated Not Issued *
05/31/2013 SpineNet Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
05/30/2013 Watson Dairy New Orleans District Office New Animal Drug/Adulterated Not Issued *
05/30/2013 Amos Conley Farms Philadelphia District Office Illegal Drug Residue 12/17/2013
05/30/2013 Kerber, Inc. Philadelphia District Office Labeling/False & Misleading Claims/Misbranded 12/17/2013
05/29/2013 Bio-Botanica, Inc. New York District Office New Drug/Misbranded Not Issued *
05/28/2013 Ebewe Pharma Ges MBH Nfg KG Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated 09/14/2015
05/28/2013 Protano & Sons Inc. Florida District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
05/28/2013 Hospira Healthcare India Pvt. Ltd. Center for Drug Evaluation and Research CGMP/Adulterated Not Issued *
05/28/2013 RPG Life Sciences Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
05/24/2013 Edwards Lifesciences, LLC Denver District Office CGMP/QSR/Medical Device Reporting/Adulterated 07/06/2016
05/24/2013 Crop Pharms New York District Office Unapproved and Misbranded New Drugs Not Issued *
05/24/2013 ConvaTec Inc. New Jersey District Office CGMP/QSR/Medical Devices/Adulterated 02/10/2016
05/24/2013 Sundial Herbal Products New York District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
05/22/2013 Metaugus Inc Atlanta District Office Dietary Supplement/Adulterated Not Issued *
05/22/2013 Bradley M. Burton Cincinnati District Office Illegal Drug Residue Not Issued *
05/22/2013 American Seaway Foods Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
05/22/2013 Swedish Match North America Inc Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 11/13/2014
05/21/2013 Teeter Creek Herbs, Inc Kansas City District Office Dietary Supplement/Labeling/False & Misleading Claims/Misbranded Not Issued *
05/21/2013 So-Low Environmental Equipment Co. Inc. Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
05/21/2013 JLM Manufacturing LLC Detroit District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 01/31/2014
05/17/2013 K S Choi Corp Los Angeles District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated 07/13/2017
05/17/2013 Contract Pharmaceutical Services of Australia Pty Ltd Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
05/16/2013 Ortho-Cycle Company Inc. Florida District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
05/16/2013 Matrix Health Products Seattle District Office Internet Marketing of Unapproved and Misbranded Drugs Not Issued *
05/15/2013 www.get-cheap-cigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/15/2013 www.smokinforfree.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/15/2013 Custom Compounding Centers, LLC Los Angeles District Office Unapproved and Misbranded New Drugs 12/15/2015
05/15/2013 Gexfix SA Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 01/07/2015
05/14/2013 Hyman Farms Dallas District Office Illegal Drug Residue 05/16/2014
05/14/2013 Joseph-Vempilly, Jose, MD Center for Drug Evaluation and Research Clinical Investigator Not Issued *
05/14/2013 Medys S.p.A. Center for Devices and Radiological Health Adulterated Device Not Issued *
05/14/2013 Shen Clinic, LLC. San Francisco District Office New Drug/Misbranded 11/27/2013
05/14/2013 Zi Xiu Tang Success, LLC Philadelphia District Office Unapproved and Misbranded New Drugs 12/06/2013
05/14/2013 Whatsa Bagel, Inc. Baltimore District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 08/04/2014
05/13/2013 Robert L. Honeycutt Cincinnati District Office Illegal Drug Residue Not Issued *
05/10/2013 Superex Canada Ltd Center for Devices and Radiological Health Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Not Issued *
05/09/2013 Apnea Sciences Inc Los Angeles District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
05/09/2013 George Boere Dairy Los Angeles District Office Illegal Drug Residue Not Issued *
05/09/2013 Valley Health/Winchester Medical Center IRB Center for Devices and Radiological Health Institutional Review Board (IRB) 07/24/2015
05/09/2013 Kronner Prototypes, Inc Seattle District Office Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Not Issued *

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