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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
June 02, 2014 Accelerated Freeze Drying Co. Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
June 02, 2014 HeartWare Inc Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
June 02, 2014 American Antibiotics, Inc. Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) July 23, 2014
May 30, 2014 www.duty-free-goods.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
May 30, 2014 Neurolumen LLC Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 30, 2014 Roundman's Smokehouse San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 29, 2014 www.cigaretteshouse.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
May 29, 2014 Luce Dairy Farm New York District Office Illegal Drug Residue Not Issued *
May 29, 2014 www.cigarette-brands.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
May 29, 2014 LSG Sky Chefs, Inc. Seattle District Office Airline Catering Facility/Labeling/Misbranded Not Issued *
May 29, 2014 Bhelliom Enterprises Corp Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
May 27, 2014 Oakdell Pharmacy, Inc Dallas District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
May 22, 2014 Shawn Bender New York District Office Illegal Drug Residues Not Issued *
May 22, 2014 Gourmail, Inc. dba Jyoti Natural Foods Philadelphia District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *
May 22, 2014 Aesthetics Systems Usa Inc Center for Devices and Radiological Health Promotion and Advertising/Misleading/Misbranded Not Issued *
May 22, 2014 Steris Isomedix Services Chicago District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 21, 2014 Staar Surgical Co. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 21, 2014 CJ Dairy Farm New York District Office Illegal Drug Residue Not Issued *
May 21, 2014 The Utopia Group LLC Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 21, 2014 Life Force of Tampa, LLC Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *



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