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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
02/06/2013 CMS Imaging, Inc., Atlanta District Office Electronic Product Radiation Control 11/13/2014
02/06/2013 CTI Foods, LLC Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
02/06/2013 Genesis Herb Company LLC Cincinnati District Office CGMP/Dietary Supplements/Adulterated/Misbranded Not Issued *
02/05/2013 Agroindustrias Mora S.A. Center for Food Safety and Applied Nutrition CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
02/05/2013 Medsys s.a. Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
02/05/2013 Futrex Incorporated Baltimore District Office Premarket Approval/Adulterated 07/22/2013
02/04/2013 DC Nutrition, Inc. Denver District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
02/04/2013 Millane Dairy Philadelphia District Office Illegal Drug Residue 07/11/2013
02/04/2013 Big Mountain Drugs Center for Drug Evaluation and Research Unapproved New Drud/Misbranded Not Issued *
02/04/2013 buy-pharma.com Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
02/01/2013 Singing River Hospital System IRB Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *
01/31/2013 Liquid Health, Inc. Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
01/31/2013 W. H. Walker Sons Inc New York District Office Juice/HACCP/Misbranded 04/21/2015
01/30/2013 Gourmet Cuisine, Inc. Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
01/30/2013 H & H Seafood Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
01/30/2013 Mkg Provisions Inc Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
01/30/2013 Pishon Trading Inc Los Angeles District Office Medical Device Reporting/Misbranded 05/30/2013
01/29/2013 M.D.R. Fitness Corp. Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated 10/18/2013
01/29/2013 FSSB Chirurgische Nadeln Gmbh Center for Devices and Radiological Health Quality System Regulation/Medical Device Reporting/Adulterated 08/06/2015
01/29/2013 M circle M Canning Co. Dallas District Office CGMP/Acidified Foods/Adulterated 07/28/2014
01/29/2013 P.A. Benjamin Manufacturing Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
01/29/2013 Sovereign Pharmaceuticals, LLC Dallas District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
01/29/2013 Bellisio Foods Inc Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
01/29/2013 www.ciggiesworld.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
01/29/2013 www.cigrattesonlinebuy.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 04/01/2015
01/29/2013 CryoLife, Inc. Atlanta District Office CGMP/QSR/Medical Devices/Adulterated 04/23/2015
01/28/2013 Paul K Katzmaier Philadelphia District Office Illegal Drug Residue 07/11/2013
01/28/2013 Bacterin International, Inc. Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
01/28/2013 Bacterin International, Inc. Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded 09/18/2013
01/25/2013 SciLabs Nutraceuticals Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
01/25/2013 Correia Dairy San Francisco District Office Illegal Drug Residue Not Issued *
01/25/2013 Tecval Medical Sarl Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
01/25/2013 R & D Ranch San Francisco District Office Illegal Drug Residue Not Issued *
01/25/2013 NX Generation Ltd. New York District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
01/24/2013 Flu & Cold Defense LLC Center for Drug Evaluation and Research Unapproved Products Related to the 2012/2013 Flu Season Not Issued *
01/23/2013 Spes Medica Srl Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
01/23/2013 Gills Onions, LLC Los Angeles District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 11/29/2013
01/23/2013 ASI Medical, Inc. Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) 04/12/2013
01/23/2013 Walk, Ed Chicago District Office Illegal Drug Residue Not Issued *
01/23/2013 Herdering, Steven Minneapolis District Office Illegal Drug Residue 04/19/2013
01/23/2013 Gioia Cheese Company Inc. Los Angeles District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
01/22/2013 Manchester Veal, LLC dba Calf Start Detroit District Office Illegal Drug Residue 04/11/2013
01/18/2013 Renati Dairy San Francisco District Office Illegal Drug Residue Not Issued *
01/18/2013 Rancho Cantera Chicago District Office Illegal Drug Residue Not Issued *
01/16/2013 Burr Favara Kansas City District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
01/16/2013 CFS Dental, Inc Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
01/16/2013 Bill Idsinga Dairy San Francisco District Office Illegal Drug Residue Not Issued *
01/16/2013 Byron Townsend Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
01/16/2013 North Star Dairy Dallas District Office Illegal Drug Residue Not Issued *
01/15/2013 Paul Bianchi, Inc. San Francisco District Office Illegal Drug Residue Not Issued *

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