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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
August 26, 2014 Andapharm, LLC Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) Not Issued *
August 25, 2014 www.cigoutlet.biz Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
August 25, 2014 Ashland Farm, LLC New York District Office Illegal Drug Residue Not Issued *
August 25, 2014 www.cigarettesbox.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
August 25, 2014 Seaview Fisheries Inc. dba Seaview Lobster Co. New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
August 22, 2014 Hoover Family Farm Cincinnati District Office Illegal Drug Residue Not Issued *
August 22, 2014 Fish Busterz, L.L.C. Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
August 21, 2014 www.discount-tobacco.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
August 21, 2014 cigarettstore.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
August 21, 2014 Lynn Born Dallas District Office Illegal Drug Residue Not Issued *
August 21, 2014 G. Wolf Enterprises, Inc. Seattle District Office Acidified Foods/Emergency Permit Control/Seafood HACCP/CGMP/Adulterated/Filth Not Issued *
August 20, 2014 Superior Cattle Feeders LLC Los Angeles District Office Illegal Drug Residue Not Issued *
August 19, 2014 Descor LLC Baltimore District Office Unapproved New Drugs/Misbranded Not Issued *
August 18, 2014 HUMAN SCIENCE FOUNDATION Los Angeles District Office Unapproved Drugs/Misbranded Not Issued *
August 18, 2014 Simply Clean Air & Water Inc. New England District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
August 18, 2014 Iradimed Corporation Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
August 15, 2014 Zions Rx Formulations Services LLC dba Rx Formuations Serv. Los Angeles District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
August 14, 2014 Big Easy Confections, L.L.C. New Orleans District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
August 14, 2014 Wickliffe Pharmaceutical Inc Cincinnati District Office Animal Drugs/Adulterated/Misbranded  Not Issued *
August 13, 2014 www.nefsak.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *



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