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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 05, 2013 Automated Ophthalmics, Inc. Baltimore District Office CGMP/QSR/Medical Devices/Adulterated February 18, 2014
June 05, 2013 Frazer, Henry A. Pharm D 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 Watson Dairy New Orleans District Office New Animal Drug/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 September 14, 2015
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 July 06, 2016
May 24, 2013 Crop Pharms New York District Office Unapproved and Misbranded New Drugs Not Issued *
May 24, 2013 ConvaTec Inc. New Jersey District Office CGMP/QSR/Medical Devices/Adulterated February 10, 2016
May 24, 2013 Sundial Herbal Products New York District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
May 22, 2013 Metaugus Inc Atlanta District Office Dietary Supplement/Adulterated Not Issued *
May 22, 2013 Bradley M. Burton Cincinnati District Office Illegal Drug Residue Not Issued *
May 22, 2013 American Seaway Foods Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 22, 2013 Swedish Match North America Inc Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded November 13, 2014
May 21, 2013 Teeter Creek Herbs, Inc Kansas City District Office Dietary Supplement/Labeling/False & Misleading Claims/Misbranded Not Issued *
May 21, 2013 So-Low Environmental Equipment Co. Inc. Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 21, 2013 JLM Manufacturing LLC Detroit District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions January 31, 2014
May 17, 2013 K S Choi Corp Los Angeles District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
May 17, 2013 Contract Pharmaceutical Services of Australia Pty Ltd Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
May 16, 2013 Ortho-Cycle Company Inc. Florida District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
May 16, 2013 Matrix Health Products Seattle District Office Internet Marketing of Unapproved and Misbranded Drugs Not Issued *
May 15, 2013 www.get-cheap-cigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
May 15, 2013 www.smokinforfree.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
May 15, 2013 Custom Compounding Centers, LLC Los Angeles District Office Unapproved and Misbranded New Drugs December 15, 2015
May 15, 2013 Gexfix SA Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated January 07, 2015
May 14, 2013 Hyman Farms Dallas District Office Illegal Drug Residue May 16, 2014
May 14, 2013 Joseph-Vempilly, Jose, MD Center for Drug Evaluation and Research Clinical Investigator Not Issued *
May 14, 2013 Medys S.p.A. Center for Devices and Radiological Health Adulterated Device Not Issued *
May 14, 2013 Shen Clinic, LLC. San Francisco District Office New Drug/Misbranded November 27, 2013
May 14, 2013 Zi Xiu Tang Success, LLC Philadelphia District Office Unapproved and Misbranded New Drugs December 06, 2013
May 14, 2013 Whatsa Bagel, Inc. Baltimore District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions August 04, 2014
May 13, 2013 Robert L. Honeycutt Cincinnati District Office Illegal Drug Residue Not Issued *
May 10, 2013 Superex Canada Ltd Center for Devices and Radiological Health Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Not Issued *
May 09, 2013 Apnea Sciences Inc Los Angeles District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
May 09, 2013 George Boere Dairy Los Angeles District Office Illegal Drug Residue Not Issued *
May 09, 2013 Valley Health/Winchester Medical Center IRB Center for Devices and Radiological Health Institutional Review Board (IRB) July 24, 2015
May 09, 2013 Kronner Prototypes, Inc Seattle District Office Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Not Issued *
May 09, 2013 Hospira Inc. Chicago District Office CGMP/QSR/Medical Devices/Adulterated October 12, 2016

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