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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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
March 22, 2013 Asada Milling Co., Ltd. Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
March 21, 2013 Dr Gumbo's New Orleans Cuisine, Inc. New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions December 07, 2015
March 21, 2013 www.123smoke.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded November 26, 2013
March 21, 2013 George Nicolas Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded December 18, 2013
March 21, 2013 paylessmoke.com@domainsbyproxy.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
March 21, 2013 www.123-cigs.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded May 01, 2013
March 20, 2013 Birkdale Medicinals LLC Detroit District Office Unapproved and Misbranded New Drugs March 06, 2014
March 20, 2013 Finemost Corporation Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
March 20, 2013 Acclarent, Inc. San Francisco District Office Medical Device Reporting/Misbranded January 22, 2014
March 20, 2013 Dressel Farms, LLC New York District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
March 19, 2013 Sri Lankan Delight, Inc. Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
March 19, 2013 Stardell Farms Inc Kansas City District Office Illegal Drug Residue July 30, 2013
March 19, 2013 Sunset Natural Products Inc. Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
March 19, 2013 Innovative Med Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated February 13, 2014
March 18, 2013 Keystone Laboratories Inc New Orleans District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
March 15, 2013 Kronebusch Farms, Inc. Minneapolis District Office Illegal Drug Residue June 10, 2013
March 15, 2013 Synticare Corp Los Angeles District Office New Drug/Labeling/False & Misleading Claims Not Issued *
March 15, 2013 Feel Tech Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
March 13, 2013 Eiken Chemical Co., Ltd. Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) September 02, 2014
March 13, 2013 Body, Mind & Soul, Inc. Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *

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