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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
July 29, 2014 Imer Barton New York District Office Illegal Drug Residue Not Issued *
July 28, 2014 Dwyer & Manning Inc Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
July 28, 2014 Connecticut Valley Tobacconist, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
July 25, 2014 Mezotrace Corporation San Francisco District Office CGMP/Dietary Supplement/Adulterated Not Issued *
July 24, 2014 Wabash Cigar Store, Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
July 24, 2014 Lao Thai Nam Corporation Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
July 24, 2014 Protech Professional Products, Inc. Florida District Office Premarket Approval/Adulterated Not Issued *
July 24, 2014 Healthtime dba Deer Garden Foods San Francisco District Office New Drug/Labeling/Misbranded Not Issued *
July 23, 2014 Casa di Pasta, Inc. Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
July 23, 2014 Julian Bakery, Inc. Los Angeles District Office False & Misleading Claims/Misbranded Not Issued *
July 22, 2014 K-Fat Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
July 22, 2014 H. A. R. Maspeth Corp. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
July 22, 2014 Hoke Farms Philadelphia District Office Unapproved New Animal Drug/Adulterated Not Issued *
July 21, 2014 Med-Mizer, Inc. Detroit District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
July 21, 2014 Smoker Friendly International LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
July 18, 2014 Contract Coating, Inc. Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) Not Issued *
July 18, 2014 PharMEDium Services, LLC Chicago District Office Compounded Drugs/CGMP Not Issued *
July 17, 2014 PROVITUS Dabrowscy, Malesa S.J. Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated Not Issued *
July 17, 2014 Schindele Enterprises dba Midwest Wholesale Kansas City District Office Unapproved/Misbranded drugs Not Issued *
July 17, 2014 Klein Laboratories, Inc. New England District Office Unapproved New Drug/Adulterated Not Issued *



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