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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
03/01/2013 Revecomed International Inc Los Angeles District Office Premarket Approval/Adulterated Not Issued *
03/01/2013 VE Valley Electronics GmbH Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded 01/23/2014
03/01/2013 Cynergy, LLC / Dermaroller Gmbh Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
03/01/2013 Five Star Dairy #2 San Francisco District Office Illegal Drug Residue Not Issued *
02/28/2013 Healthwest Minerals, Inc. dba Mt. Capra Products Seattle District Office CGMP/Dietary Supplements/Adulterated Not Issued *
02/28/2013 Interlab S.r.l. Center for Devices and Radiological Health Medical Devices/Adulterated 05/07/2015
02/28/2013 Ben E Keith Company Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 11/07/2014
02/26/2013 Amresco LLC Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
02/26/2013 Best Seasonings Group Inc. dba Sofrito Montero Inc. San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
02/26/2013 www.topluckmall.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
02/25/2013 Robert A. Miller Philadelphia District Office Illegal Drug Residue 12/06/2013
02/25/2013 Da Rosa Dairy San Francisco District Office Illegal Drug Residue Not Issued *
02/25/2013 Altasource LLC DBA Metalabs LLC Atlanta District Office Unapproved and Misbranded New Drugs Not Issued *
02/22/2013 Prodigy Diabetes Care, LLC Atlanta District Office Medical Device Reporting/Misbranded 04/10/2014
02/22/2013 Organics Corporation of America DBA Ambix Laboratories New Jersey District Office CGMP/Dietary Supplements/Adulterated 04/22/2014
02/22/2013 TOADS LLC Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
02/21/2013 Graham Dairy New Orleans District Office Illegal Drug Residue 03/19/2013
02/21/2013 Apotex Inc Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/Misbranded 05/02/2014
02/21/2013 Kral X-ray Inc. Atlanta District Office Electronic Product Radiation Control Not Issued *
02/21/2013 Boyd Mahrt and Ingrid Mahrt San Francisco District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
02/21/2013 Alfred Louie Inc San Francisco District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
02/20/2013 Capco Custom Packaging Inc Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated 02/17/2015
02/20/2013 Atossa Genetics, Inc. Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
02/20/2013 Ferry Brothers Partnership New England District Office Illegal Drug Residue Not Issued *
02/20/2013 Jubilant HollisterStier General Partnership Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated 09/05/2014
02/20/2013 Carrizozo Orchard Denver District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 11/22/2016
02/20/2013 CoRE Labs, LLC Denver District Office Medical Device Reporting/Misbranded 12/09/2014
02/20/2013 An Xuyen Bakery, Inc. Seattle District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
02/19/2013 Abbey Color, Inc. Philadelphia District Office CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
02/15/2013 GRANTECH CO., LTD. Center for Devices and Radiological Health Quality System Regulation/Medical Device Reporting/Adulterated Not Issued *
02/14/2013 Laclede Inc Los Angeles District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
02/13/2013 Stonington Sea Products, LLC New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
02/13/2013 Kanetoku Corporation Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
02/13/2013 A & M Teixeira Dairy San Francisco District Office Illegal Drug Residue Not Issued *
02/13/2013 Integra Neurosciences PR, Inc. San Juan District Office CGMP/QSR/Medical Devices/Adulterated 01/14/2015
02/13/2013 Hi Hills Farm Cincinnati District Office Illegal Drug Residue Not Issued *
02/12/2013 Computer Times Publishing Inc. dba Sushi Chef San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
02/11/2013 Supplementality LLC Center for Food Safety and Applied Nutrition Unapproved Products Related to the 2012/2013 Flu Season Not Issued *
02/11/2013 Vitalmax Vitamins Center for Food Safety and Applied Nutrition Unapproved Products Related to the 2012/2013 Flu Season Not Issued *
02/11/2013 Arizona Hydroponic Farming, LLC Los Angeles District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated 10/23/2013
02/11/2013 Kosher Vitamin Express Center for Food Safety and Applied Nutrition Unapproved Products Related to the 2012/2013 Flu Season Not Issued *
02/11/2013 Discount Online Pharmacy Center for Drug Evaluation and Research Unapproved Products Related to the 2012/2013 Flu Season Not Issued *
02/11/2013 Medsnoscript Center for Drug Evaluation and Research Unapproved products related to the 2012/2013 flu Season Not Issued *
02/11/2013 Secure Medical Inc Center for Drug Evaluation and Research Unapproved Products Related to the 2012/2013 Flu Season Not Issued *
02/11/2013 Sun Drug Store Center for Drug Evaluation and Research Unapproved Products Related to the 2012/2013 Flu Season Not Issued *
02/11/2013 Kreativ Health Inc Dba Natural Food Supplements Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated 11/18/2014
02/11/2013 Oasis Consumer Healthcare, LLC Center for Drug Evaluation and Research Unapproved products related to the 2012/2013 flu Season Not Issued *
02/08/2013 Tan Extreme Inc Chicago District Office Premarket Approval Application (PMA) Not Issued *
02/08/2013 Beehive Botanicals, Inc. Minneapolis District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated 06/12/2015
02/07/2013 University of Berkley Center for Biologics Evaluation and Research Unapproved Products Related to the 2012/2013 Flu Season Not Issued *

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