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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
November 24, 2014 Jansen Enterprises, LLC dba HealthWorksUSA Minneapolis District Office New Drug/Labeling/Misbranded Not Issued *
November 24, 2014 U S Infusion, Inc. dba Truecare Biomedix-USA Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
November 24, 2014 Sociedad Guidomar Ltda Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
November 24, 2014 Cau Tre Export Goods Processing Joint Stock Company Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 24, 2014 My Lady's Manor Farm, Inc. Baltimore District Office Illegal Drug Residue Not Issued *
November 24, 2014 Continental Mills/True Bliss Confections Center for Food Safety and Applied Nutrition Food Labeling/Misbranded Not Issued *
November 21, 2014 http://www.cigarettes24.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
November 21, 2014 Fioravanti Custom Products DBA Essential Wholesale & Labs Seattle District Office New Drugs/Cosmetics Labeling and Marketing with Drug Claims Not Issued *
November 20, 2014 Long Island Pharmaceuticals LLC New York District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
November 20, 2014 Hirsch's Dairy Farm New York District Office Illegal Drug Residue Not Issued *
November 20, 2014 New Hope Fertility Center New York District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Not Issued *
November 20, 2014 Urban Moonshine, Inc. New England District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
November 19, 2014 Sherwood Food Distributors, LLC Detroit District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
November 19, 2014 LifeSilver Center for Food Safety and Applied Nutrition Unapproved New Drugs/Misbranded Not Issued *
November 19, 2014 Floyd Raber Cincinnati District Office Illegal Drug Residue Not Issued *
November 18, 2014 Bodyhealth.com, LLC Center for Food Safety and Applied Nutrition Unapproved New Drugs/Misbranded Not Issued *
November 18, 2014 Ebola-C Inc Center for Food Safety and Applied Nutrition Unapproved New Drugs/Misbranded Not Issued *
November 17, 2014 Respironics California Inc Los Angeles District Office Medical Device Reporting/Misbranded Not Issued *
November 17, 2014 Walnut Creek Kitchens, Inc. Cincinnati District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   Not Issued *
November 14, 2014 Hickory Smokehouse of Las Vegas, Inc. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *



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