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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2014 Warning Letters

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
08/12/2014 Wise, John M. M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
08/12/2014 Masimo Corporation Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated 05/25/2017
08/12/2014 Premier Organics Inc. Center for Food Safety and Applied Nutrition Food Labeling/Misbranded 11/07/2014
08/11/2014 Spacelabs Healthcare Inc Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
08/11/2014 Brookhurst Mill Los Angeles District Office CGMP/Medicated Feeds/Adulterated/Misbranded 12/05/2014
08/11/2014 Marel Corporation New England District Office CGMP/QSR/Medical Devices/Adulterated 09/17/2015
08/11/2014 Carousel Solutions LLC dba Xtract Solutions Seattle District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
08/08/2014 Chromsystems Instruments & Chemicals GmbH Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 11/17/2016
08/08/2014 Union Square Medical Imaging & Mammography New York District Office Mammography Quality Standards Not Issued *
08/08/2014 EnerHealth Botanicals, LLC Denver District Office CGMP/Dietary Supplement/Adulterated/Misbranded 06/29/2016
08/08/2014 O'Dell Farms New York District Office Illegal Drug Residue Not Issued *
08/08/2014 www.e-tobaccos.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 03/27/2015
08/08/2014 Nidek Inc San Francisco District Office CGMP/QSR/Medical Devices/Adulterated 08/25/2015
08/08/2014 Fessenden Dairy, LLC New York District Office Illegal Drug Residue Not Issued *
08/08/2014 Childrens Medical Ventures Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
08/08/2014 Dennis Loppnow Minneapolis District Office Illegal Drug Residue 12/11/2014
08/08/2014 Greiner Bio One Brasil Produtos Medicos Hospitalares Ltda. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 08/03/2016
08/07/2014 221 Enterprises, LLC. Baltimore District Office Unapproved New Drugs/Misbranded Not Issued *
08/07/2014 Explora Laboratories Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) Not Issued *
08/07/2014 Colgate Oral Pharmaceuticals, Inc. Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) 08/21/2014
08/07/2014 Michigan Brands, Inc. Detroit District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
08/07/2014 Korea United Pharm Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) 03/04/2015
08/06/2014 Vernon W. Zimmerman Philadelphia District Office Illegal Drug Residue Not Issued *
08/05/2014 F. & S. Maranto, LLC Baltimore District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
08/05/2014 Garden of Flavor LLC Cincinnati District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 04/07/2016
08/05/2014 Goodlife Juices Philadelphia District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 07/17/2015
08/05/2014 o.m.t. Oberflachen - und Materialtechnologie Gmbh Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
08/05/2014 www.smokesfourless.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 12/02/2014
08/05/2014 Engineering Nutrition Los Angeles District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
08/04/2014 Vygon Gmbh & Co. KG Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
08/04/2014 Handsome Industrial (H.K.) Co., LTD Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
08/04/2014 Oberholtzer, Joseph N. Philadelphia District Office Illegal Drug Residue 08/04/2015
08/01/2014 Peter Bacle dba Stock Island Lobster Company Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
08/01/2014 Geetanjali Inc., d/b/a Tobacco World Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 09/04/2014
07/31/2014 Faihopity Farms, LP Philadelphia District Office Illegal Drug Residue 02/12/2015
07/31/2014 Dean and Jean Mikalunas New York District Office Illegal Drug Residue Not Issued *
07/31/2014 Wang Globalnet New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
07/31/2014 Iberia Foods Company of New York, Inc New York District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   Not Issued *
07/30/2014 Taiyo Seafood NY Inc New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
07/30/2014 Plexus Worldwide Inc Los Angeles District Office New Drug/Misbranded Not Issued *
07/29/2014 MKL DIAGNOSTICS AB Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
07/29/2014 Medinol Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 02/11/2015
07/29/2014 Imer Barton New York District Office Illegal Drug Residue Not Issued *
07/29/2014 M & C Catering LLC Atlanta District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated 08/21/2014
07/28/2014 Tianjin New Bay Bioresearch Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
07/28/2014 Dwyer & Manning Inc Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 01/15/2015
07/28/2014 Connecticut Valley Tobacconist, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 09/15/2015
07/28/2014 Repromed Fertility Center Dallas District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Not Issued *
07/25/2014 AMS Health Sciences Dallas District Office Unapproved New Drugs/Misbranded 04/25/2016
07/25/2014 William Rausch Cincinnati District Office Illegal Drug Residue Not Issued *

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