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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2013 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
August 01, 2013 Lumina Health Products, Inc. Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
July 31, 2013 LumiQuick Diagnostics Inc. San Francisco District Office Premarket Approval/Adulterated Not Issued *
July 31, 2013 Wonjin Mulsan Co., Ltd. Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
July 31, 2013 Peter Schiff Enterprises New Orleans District Office Quality System Regulation for Medical Devices/Adulterated Not Issued *
July 31, 2013 Russell Hall Seafood, Inc. Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
July 30, 2013 Trademark Co., Inc., d/b/a Golden Valley Tobacco Center for Tobacco Products Modified Risk Tobacco Products March 10, 2014
July 30, 2013 Aarti Drugs Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
July 30, 2013 BnB Enterprise LLC Center for Tobacco Products Modified Risk Tobacco Products July 01, 2014
July 30, 2013 CHUNGDO PHARM. CO. LTD. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
July 30, 2013 Tobacco Outlet Express LLC Center for Tobacco Products Modified Risk Tobacco Products October 07, 2013
July 30, 2013 RSB Tobacco Inc Center for Tobacco Products Modified Risk Tobacco Products September 17, 2013
July 29, 2013 Seafood Wholesalers, Limited Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
July 26, 2013 www.desismokes.com Center for Tobacco Products Modified Risk Tobacco Products August 08, 2013
July 26, 2013 Roth, Lonny M. Minneapolis District Office Illegal Drug Residue March 17, 2014
July 26, 2013 Philemon Pty Ltd Center for Food Safety and Applied Nutrition Food Labeling/Misbranded Not Issued *
July 25, 2013 Brockway Hilltop Farms LLC New York District Office Illegal Drug Residue Not Issued *
July 24, 2013 Northern Digital Inc. Center for Devices and Radiological Health Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Not Issued *
July 24, 2013 Sinan Dairy Farm Philadelphia District Office Illegal Drug Residue January 16, 2014
July 24, 2013 Donald Potts Philadelphia District Office Illegal Drug Residue Not Issued *
July 23, 2013 Natural Products Services, Inc. Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *



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