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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 25, 2013 Agnesian Healthcare IRB Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *
March 22, 2013 Mega Sun Inc Kansas City District Office CGMP for Medical Device/QSR/Adulterated Not Issued *
March 22, 2013 Alexion Pharmaceuticals, Inc. New England District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated Not Issued *
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 *
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 Foremost Foods International, Inc./Seafood City Los Angeles District Office Labeling/False & Misleading Claims/Misbranded 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 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 08, 2013 Algaen Corporation Atlanta District Office Unapproved New Drug/Adulterated/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 07, 2013 Lodato Gennaro & C S.p.A. Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Misbranded Not Issued *
March 06, 2013 Shatila Food Products, Inc. Detroit District Office Labeling/False & Misleading Claims/Misbranded Not Issued *
March 06, 2013 Jerland Farm Minneapolis District Office Illegal Drug Residue June 10, 2013
March 06, 2013 Continental Medical Labs, Inc. Minneapolis District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated November 19, 2013
March 06, 2013 Stryker Instruments Div. of Stryker Corporation Detroit District Office CGMP/QSR/Medical Devices/Adulterated January 14, 2014
March 06, 2013 Johann Dairy San Francisco District Office Illegal Drug Residue Not Issued *
March 05, 2013 Roy's Fishery San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
March 05, 2013 Fresenius Medical Care, North America Denver District Office CGMP/QSR/Medical Devices/Adulterated April 30, 2015
March 05, 2013 Primarch Manufacturing, Inc. Los Angeles District Office CGMP/Dietary Supplements/Adulterated March 25, 2014
March 05, 2013 Fisioline s.r.l. Center for Devices and Radiological Health Quality System Regulation/Medical Device Reporting/Adulterated Not Issued *
March 04, 2013 Ivy Farms, Inc. New England District Office Illegal Drug Residue Not Issued *
March 04, 2013 Mitsutoyo Co. Ltd., Hakodate Plant Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
March 04, 2013 Correia Family Limited Partnership (dba Wynsum Holsteins) New England District Office Illegal Drug Residue Not Issued *
March 01, 2013 Desert Rose Manufacturing Denver District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated July 13, 2016
March 01, 2013 VE Valley Electronics GmbH Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded January 23, 2014
March 01, 2013 Linet Spol. S.r.o. Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded May 08, 2013
March 01, 2013 Five Star Dairy #2 San Francisco District Office Illegal Drug Residue Not Issued *

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