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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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
July 28, 2014 Repromed Fertility Center Dallas District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Not Issued *
July 25, 2014 William Rausch Cincinnati District Office Illegal Drug Residue Not Issued *
July 25, 2014 Mezotrace Corporation San Francisco District Office CGMP/Dietary Supplement/Adulterated Not Issued *
July 25, 2014 AMS Health Sciences Dallas District Office Unapproved New Drugs/Misbranded Not Issued *
July 24, 2014 Healthtime dba Deer Garden Foods San Francisco District Office New Drug/Labeling/Misbranded Not Issued *
July 24, 2014 Protech Professional Products, Inc. Florida District Office Premarket Approval/Adulterated 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 Wabash Cigar Store, Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded September 04, 2014
July 23, 2014 Julian Bakery, Inc. Los Angeles District Office False & Misleading Claims/Misbranded February 11, 2015
July 23, 2014 Casa di Pasta, Inc. Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions April 15, 2015
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 K-Fat Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
July 22, 2014 Hoke Farms Philadelphia District Office Illegal Drug Residue May 08, 2015
July 21, 2014 Smoker Friendly International LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded September 19, 2014
July 21, 2014 Med-Mizer, Inc. Detroit District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
July 18, 2014 Calaire Chimie S.A.S. Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) Not Issued *
July 18, 2014 Bioland Technology Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
July 18, 2014 PharMEDium Services, LLC Chicago District Office Compounded Drugs/CGMP 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 17, 2014 PROVITUS Dabrowscy, Malesa S.J. Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated Not Issued *

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