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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 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 Boyd Mahrt and Ingrid Mahrt San Francisco District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
February 21, 2013 Apotex Inc Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/Misbranded May 02, 2014
February 21, 2013 Alfred Louie Inc San Francisco District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
February 21, 2013 Kral X-ray Inc. Atlanta District Office Electronic Product Radiation Control Not Issued *
February 20, 2013 Carrizozo Orchard Denver District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
February 20, 2013 CoRE Labs, LLC Denver District Office Medical Device Reporting/Misbranded December 09, 2014
February 20, 2013 Atossa Genetics, Inc. Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded 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 Jubilant HollisterStier General Partnership Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated September 05, 2014
February 20, 2013 Ferry Brothers Partnership New England District Office Illegal Drug Residue Not Issued *
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 Hi Hills Farm Cincinnati 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 Stonington Sea Products, LLC New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *

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