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

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