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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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2013 Warning Letters

Posted on April 30, 2013

Letter Issue Date Company Name Issuing Office Subject Close Out Date
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 Stardell Farms Inc Kansas City District Office Illegal Drug Residue Not Issued *
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 Not Issued *
March 15, 2013 Feel Tech Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
March 15, 2013 Synticare Corp Los Angeles District Office New Drug/Labeling/False & Misleading Claims 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) Not Issued *
March 13, 2013 Foremost Foods International, Inc./Seafood City Los Angeles District Office Labeling/False & Misleading Claims/Misbranded Not Issued *
March 13, 2013 Coral Rock Man, Inc. Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
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 *
March 12, 2013 Natural Medicine Associates, Inc Florida District Office Unapproved and Misbranded New Drugs Not Issued *
March 12, 2013 Yoli, Inc. dba Mi Costenita Chicago District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
March 12, 2013 Oak Grove Farm Baltimore District Office Illegal Drug Residue Not Issued *
March 12, 2013 NuVasive Inc Los Angeles District Office Premarket Approval/Misbranded/Adulterated Not Issued *
March 07, 2013 Lodato Gennaro & C S.p.A. Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Misbranded Not Issued *
March 07, 2013 Medi-Fare Drug and Home Health Center Atlanta District Office CGMP for Finished Pharmaceutical/Unapproved New Drugs/Adulterated/Misbranded Not Issued *
March 07, 2013 www.djarumblack-clovecigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
March 07, 2013 Machado Dairy Farms Dairy #2 San Francisco District Office Illegal Drug Residue Not Issued *
March 06, 2013 Stryker Instruments Div. of Stryker Corporation Detroit District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
March 06, 2013 Jerland Farm Minneapolis District Office Illegal Drug Residue Not Issued *


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