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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 15, 2014 Zions Rx Formulations Services LLC dba Rx Formuations Serv. Los Angeles District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
August 14, 2014 Wickliffe Pharmaceutical Inc Cincinnati District Office Animal Drugs/Adulterated/Misbranded  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 13, 2014 www.nefsak.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
August 12, 2014 Ad-Med Biotechnology, LLC Detroit District Office Unapproved New Drugs/Misbranded Not Issued *
August 12, 2014 The Compounding Shop, Inc. Florida District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
August 12, 2014 Hillcrest Dairy Philadelphia District Office Illegal Drug Residue Not Issued *
August 12, 2014 EWSG, Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
August 12, 2014 John M. Wise, M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
August 12, 2014 Masimo Corporation Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
August 12, 2014 Premier Organics Inc. Center for Food Safety and Applied Nutrition Food Labeling/Misbranded Not Issued *
August 11, 2014 Spacelabs Healthcare Inc Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
August 11, 2014 Brookhurst Mill Los Angeles District Office CGMP/Medicated Feeds/Adulterated/Misbranded December 05, 2014
August 11, 2014 Marel Corporation New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
August 11, 2014 Carousel Solutions LLC dba Xtract Solutions Seattle 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 EnerHealth Botanicals, LLC Denver District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
August 08, 2014 O'Dell Farms 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 Not Issued *
August 08, 2014 Nidek Inc San Francisco District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *



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