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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
February 06, 2013 CTI Foods, LLC Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
February 06, 2013 Genesis Herb Company LLC Cincinnati District Office CGMP/Dietary Supplements/Adulterated/Misbranded Not Issued *
February 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 *
February 05, 2013 Medsys s.a. Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
February 05, 2013 Futrex Incorporated Baltimore District Office Premarket Approval/Adulterated July 22, 2013
February 04, 2013 DC Nutrition, Inc. Denver District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
February 04, 2013 Millane Dairy Philadelphia District Office Illegal Drug Residue July 11, 2013
February 04, 2013 Big Mountain Drugs Center for Drug Evaluation and Research Unapproved New Drud/Misbranded Not Issued *
February 04, 2013 buy-pharma.com Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
February 01, 2013 Singing River Hospital System IRB Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *
January 31, 2013 Liquid Health, Inc. Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
January 31, 2013 W. H. Walker Sons Inc New York District Office Juice/HACCP/Misbranded April 21, 2015
January 30, 2013 Gourmet Cuisine, Inc. Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
January 30, 2013 H & H Seafood Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
January 30, 2013 Mkg Provisions Inc Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
January 30, 2013 Pishon Trading Inc Los Angeles District Office Medical Device Reporting/Misbranded May 30, 2013
January 29, 2013 M.D.R. Fitness Corp. Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated October 18, 2013
January 29, 2013 FSSB Chirurgische Nadeln Gmbh Center for Devices and Radiological Health Quality System Regulation/Medical Device Reporting/Adulterated August 06, 2015
January 29, 2013 M circle M Canning Co. Dallas District Office CGMP/Acidified Foods/Adulterated July 28, 2014
January 29, 2013 P.A. Benjamin Manufacturing Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
January 29, 2013 Sovereign Pharmaceuticals, LLC Dallas District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
January 29, 2013 Bellisio Foods Inc Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
January 29, 2013 www.ciggiesworld.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
January 29, 2013 www.cigrattesonlinebuy.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded April 01, 2015
January 29, 2013 CryoLife, Inc. Atlanta District Office CGMP/QSR/Medical Devices/Adulterated April 23, 2015
January 28, 2013 Paul K Katzmaier Philadelphia District Office Illegal Drug Residue July 11, 2013
January 28, 2013 Bacterin International, Inc. Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
January 28, 2013 Bacterin International, Inc. Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded September 18, 2013
January 25, 2013 SciLabs Nutraceuticals Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
January 25, 2013 Correia Dairy San Francisco District Office Illegal Drug Residue Not Issued *
January 25, 2013 Tecval Medical Sarl Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
January 25, 2013 R & D Ranch San Francisco District Office Illegal Drug Residue Not Issued *
January 25, 2013 NX Generation Ltd. New York District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
January 24, 2013 Flu & Cold Defense LLC Center for Drug Evaluation and Research Unapproved Products Related to the 2012/2013 Flu Season Not Issued *
January 23, 2013 Spes Medica Srl Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
January 23, 2013 Gills Onions, LLC Los Angeles District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions November 29, 2013
January 23, 2013 ASI Medical, Inc. Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) April 12, 2013
January 23, 2013 Walk, Ed Chicago District Office Illegal Drug Residue Not Issued *
January 23, 2013 Herdering, Steven Minneapolis District Office Illegal Drug Residue April 19, 2013
January 23, 2013 Gioia Cheese Company Inc. Los Angeles District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
January 22, 2013 Manchester Veal, LLC dba Calf Start Detroit District Office Illegal Drug Residue April 11, 2013
January 18, 2013 Renati Dairy San Francisco District Office Illegal Drug Residue Not Issued *
January 18, 2013 Rancho Cantera Chicago District Office Illegal Drug Residue Not Issued *
January 16, 2013 Burr Favara Kansas City District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
January 16, 2013 CFS Dental, Inc Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
January 16, 2013 Bill Idsinga Dairy San Francisco District Office Illegal Drug Residue Not Issued *
January 16, 2013 Byron Townsend Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
January 16, 2013 North Star Dairy Dallas District Office Illegal Drug Residue Not Issued *
January 15, 2013 Paul Bianchi, Inc. San Francisco District Office Illegal Drug Residue Not Issued *
January 15, 2013 www.order-cheap-cigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded April 14, 2014

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