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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 08, 2014 Nidek Inc San Francisco District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
August 08, 2014 Fessenden Dairy, LLC New York District Office Illegal Drug Residue Not Issued *
August 08, 2014 Childrens Medical Ventures Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
August 08, 2014 Dennis Loppnow Minneapolis District Office Illegal Drug Residue December 11, 2014
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 07, 2014 Explora Laboratories Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) 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 06, 2014 Vernon W. Zimmerman Philadelphia District Office Illegal Drug Residue Not Issued *
August 05, 2014 Garden of Flavor LLC Cincinnati District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
August 05, 2014 Goodlife Juices Philadelphia District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
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 Engineering Nutrition Los Angeles District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
August 04, 2014 Oberholtzer, Joseph N. Philadelphia District Office Illegal Drug Residue Not Issued *
August 01, 2014 Peter Bacle dba Stock Island Lobster Company Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
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
July 31, 2014 Faihopity Farms, LP Philadelphia District Office Illegal Drug Residue Not Issued *
July 31, 2014 Dean and Jean Mikalunas New York District Office New Animal Drug/Adulterated Not Issued *
July 31, 2014 Wang Globalnet New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *



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