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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 12, 2014 Masimo Corporation Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
August 12, 2014 The Compounding Shop, Inc. Florida District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
August 12, 2014 John M. Wise, M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
August 12, 2014 Hillcrest Dairy Philadelphia District Office Illegal Drug Residue Not Issued *
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 Not Issued *
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 11, 2014 Brookhurst Mill Los Angeles District Office CGMP/Medicated Feeds/Adulterated/Misbranded Not Issued *
August 11, 2014 Spacelabs Healthcare Inc Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded 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 *
August 08, 2014 Fessenden Dairy, LLC New York District Office Illegal Drug Residue Not Issued *
August 08, 2014 Union Square Medical Imaging & Mammography New York District Office Mammography Quality Standards Not Issued *
August 08, 2014 Childrens Medical Ventures Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
August 08, 2014 EnerHealth Botanicals, LLC Denver District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
August 08, 2014 Dennis Loppnow Minneapolis District Office Illegal Drug Residue Not Issued *
August 08, 2014 O'Dell Farms New York District Office Illegal Drug Residue Not Issued *
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) Not Issued *



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