• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

2013 Warning Letters

 
-
Letter Issue Date Company Name Issuing Office Subject Close Out Date
03/25/2013 Peking Medicine Manufactory Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Unapproved/Misbranded Not Issued *
03/25/2013 Agnesian Healthcare IRB Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *
03/22/2013 Mega Sun Inc Kansas City District Office CGMP for Medical Device/QSR/Adulterated Not Issued *
03/22/2013 Alexion Pharmaceuticals, Inc. New England District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated Not Issued *
03/22/2013 Asada Milling Co., Ltd. Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
03/21/2013 Dr Gumbo's New Orleans Cuisine, Inc. New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 12/07/2015
03/21/2013 www.123smoke.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 11/26/2013
03/21/2013 George Nicolas Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 12/18/2013
03/21/2013 paylessmoke.com@domainsbyproxy.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
03/21/2013 www.123-cigs.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 05/01/2013
03/20/2013 Birkdale Medicinals LLC Detroit District Office Unapproved and Misbranded New Drugs 03/06/2014
03/20/2013 Finemost Corporation Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
03/20/2013 Acclarent, Inc. San Francisco District Office Medical Device Reporting/Misbranded 01/22/2014
03/20/2013 Dressel Farms, LLC New York District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
03/19/2013 Sri Lankan Delight, Inc. Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
03/19/2013 Stardell Farms Inc Kansas City District Office Illegal Drug Residue 07/30/2013
03/19/2013 Sunset Natural Products Inc. Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
03/19/2013 Innovative Med Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated 02/13/2014
03/18/2013 Keystone Laboratories Inc New Orleans District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
03/15/2013 Kronebusch Farms, Inc. Minneapolis District Office Illegal Drug Residue 06/10/2013
03/15/2013 Synticare Corp Los Angeles District Office New Drug/Labeling/False & Misleading Claims Not Issued *
03/15/2013 Feel Tech Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
03/13/2013 Eiken Chemical Co., Ltd. Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) 09/02/2014
03/13/2013 Body, Mind & Soul, Inc. Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
03/13/2013 Coral Rock Man, Inc. Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
03/13/2013 Foremost Foods International, Inc./Seafood City Los Angeles District Office Labeling/False & Misleading Claims/Misbranded Not Issued *
03/12/2013 Yoli, Inc. dba Mi Costenita Chicago District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 05/06/2014
03/12/2013 Oak Grove Farm Baltimore District Office Illegal Drug Residue Not Issued *
03/12/2013 NuVasive Inc Los Angeles District Office Premarket Approval/Misbranded/Adulterated 03/04/2014
03/12/2013 Natural Medicine Associates, Inc Florida District Office Unapproved and Misbranded New Drugs Not Issued *
03/08/2013 Algaen Corporation Atlanta District Office Unapproved New Drug/Adulterated/Misbranded Not Issued *
03/07/2013 Medi-Fare Drug and Home Health Center Atlanta District Office CGMP for Finished Pharmaceutical/Unapproved New Drugs/Adulterated/Misbranded Not Issued *
03/07/2013 www.djarumblack-clovecigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
03/07/2013 Machado Dairy Farms Dairy #2 San Francisco District Office Illegal Drug Residue Not Issued *
03/07/2013 Lodato Gennaro & C S.p.A. Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Misbranded Not Issued *
03/06/2013 Shatila Food Products, Inc. Detroit District Office Labeling/False & Misleading Claims/Misbranded Not Issued *
03/06/2013 Jerland Farm Minneapolis District Office Illegal Drug Residue 06/10/2013
03/06/2013 Continental Medical Labs, Inc. Minneapolis District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated 11/19/2013
03/06/2013 Stryker Instruments Div. of Stryker Corporation Detroit District Office CGMP/QSR/Medical Devices/Adulterated 01/14/2014
03/06/2013 Johann Dairy San Francisco District Office Illegal Drug Residue Not Issued *
03/05/2013 Roy's Fishery San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
03/05/2013 Fresenius Medical Care, North America Denver District Office CGMP/QSR/Medical Devices/Adulterated 04/30/2015
03/05/2013 Primarch Manufacturing, Inc. Los Angeles District Office CGMP/Dietary Supplements/Adulterated 03/25/2014
03/05/2013 Fisioline s.r.l. Center for Devices and Radiological Health Quality System Regulation/Medical Device Reporting/Adulterated Not Issued *
03/04/2013 Ivy Farms, Inc. New England District Office Illegal Drug Residue Not Issued *
03/04/2013 Mitsutoyo Co. Ltd., Hakodate Plant Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated 09/07/2017
03/04/2013 Correia Family Limited Partnership (dba Wynsum Holsteins) New England District Office Illegal Drug Residue Not Issued *
03/01/2013 Desert Rose Manufacturing Denver District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated 07/13/2016
03/01/2013 VE Valley Electronics GmbH Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded 01/23/2014
03/01/2013 Linet Spol. S.r.o. Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded 05/08/2013

-