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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

2013 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
February 11, 2013 Supplementality LLC Center for Food Safety and Applied Nutrition Unapproved Products Related to the 2012/2013 Flu Season Not Issued *
February 11, 2013 Vitalmax Vitamins Center for Food Safety and Applied Nutrition Unapproved Products Related to the 2012/2013 Flu Season Not Issued *
February 08, 2013 Tan Extreme Inc Chicago District Office Premarket Approval Application (PMA) Not Issued *
February 08, 2013 Beehive Botanicals, Inc. Minneapolis District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
February 07, 2013 University of Berkley Center for Biologics Evaluation and Research Unapproved Products Related to the 2012/2013 Flu Season Not Issued *
February 06, 2013 Genesis Herb Company LLC Cincinnati District Office CGMP/Dietary Supplements/Adulterated/Misbranded Not Issued *
February 06, 2013 CMS Imaging, Inc., Atlanta District Office Electronic Product Radiation Control Not Issued *
February 06, 2013 CTI Foods, LLC Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
February 05, 2013 Medsys s.a. Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
February 05, 2013 Futrex Incorporated Baltimore District Office Premarket Approval/Adulterated July 22, 2013
February 05, 2013 Agroindustrias Mora S.A. Center for Food Safety and Applied Nutrition CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
February 04, 2013 buy-pharma.com Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
February 04, 2013 DC Nutrition, Inc. Denver District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
February 04, 2013 Big Mountain Drugs Center for Drug Evaluation and Research Unapproved New Drud/Misbranded Not Issued *
February 04, 2013 Millane Dairy Philadelphia District Office Illegal Drug Residue July 11, 2013
February 01, 2013 Singing River Hospital System IRB Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *
January 31, 2013 W. H. Walker Sons Inc New York District Office Juice/HACCP/Misbranded Not Issued *
January 31, 2013 Liquid Health, Inc. Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
January 30, 2013 Pishon Trading Inc Los Angeles District Office Medical Device Reporting/Misbranded May 30, 2013
January 30, 2013 Gourmet Cuisine, Inc. Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *



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