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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 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 11, 2014 Brookhurst Mill Los Angeles District Office CGMP/Medicated Feeds/Adulterated/Misbranded Not Issued *
August 11, 2014 Marel Corporation New England 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 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 *
August 08, 2014 Fessenden Dairy, LLC New York District Office Illegal Drug Residue Not Issued *
August 08, 2014 Dennis Loppnow Minneapolis District Office Illegal Drug Residue Not Issued *
August 08, 2014 Childrens Medical Ventures Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated 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 *
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 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 *



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