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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
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 Dressel Farms, LLC New York District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
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 19, 2013 Stardell Farms Inc Kansas City District Office Illegal Drug Residue July 30, 2013
March 19, 2013 Sri Lankan Delight, Inc. Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
March 18, 2013 Keystone Laboratories Inc New Orleans District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded 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 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 13, 2013 Foremost Foods International, Inc./Seafood City Los Angeles District Office Labeling/False & Misleading Claims/Misbranded 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 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 Eiken Chemical Co., Ltd. Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) September 02, 2014
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 March 04, 2014
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 May 06, 2014
March 08, 2013 Algaen Corporation Atlanta District Office Unapproved New Drug/Adulterated/Misbranded Not Issued *
March 07, 2013 Machado Dairy Farms Dairy #2 San Francisco District Office Illegal Drug Residue Not Issued *



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