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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
March 17, 2014 Ultradent Products, Inc. Denver District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
March 17, 2014 E. W. Mailhot Sausage Company New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
March 14, 2014 Dexcom Inc Los Angeles District Office Medical Device Reporting Regulation/Misbranded Not Issued *
March 14, 2014 Pattanam D. Srinivasan, MD Center for Devices and Radiological Health Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device Not Issued *
March 13, 2014 Libi Labs, Inc. Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
March 12, 2014 Ocean Wave Products, Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
March 11, 2014 Royal Foods Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
March 11, 2014 Colorado Histo-Prep Center for Drug Evaluation and Research Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies Not Issued *
March 11, 2014 Teleflex Medical Chicago District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
March 07, 2014 Russian Products, Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
March 07, 2014 Martin, Marlin Detroit District Office Illegal Drug Residue Not Issued *
March 07, 2014 Pentec Health Philadelphia District Office Drug Product/Adulterated Not Issued *
March 07, 2014 Deseo Rebajar San Juan District Office Unapproved and Misbranded New Drugs Not Issued *
March 07, 2014 Hospira, Inc. Atlanta District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
March 06, 2014 Britto Seafoods Exports Pvt. Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
March 06, 2014 Golden Crown Bakery, Inc. dba Panzanella Bread Company Seattle District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
March 06, 2014 La Tienda, Inc. Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
March 06, 2014 Smruthi Organics Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/HPLC Not Issued *
March 06, 2014 Han Sung Sikpoom Trading Co. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
March 06, 2014 Hong Lee Trading Inc New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *



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