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

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