FDA Warning Letters Posted on October 22, 2013

Posted on October 22, 2013

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
October 18, 2013	R82 A/S	Center for Devices and Radiological Health	Quality System Regulation for Medical Devices/Adulterated	Not Issued *
October 11, 2013	Usp Labs	Center for Food Safety and Applied Nutrition	Dietary Supplement/Adulterated	Not Issued *
October 09, 2013	Virtual Sun, LLC	New Orleans District Office	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
October 09, 2013	www.serenawholesaler.com	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded	Not Issued *
October 09, 2013	www.usatobacco.biz	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded	Not Issued *
October 02, 2013	Jason Martindale	New York District Office	Illegal Drug Residue	Not Issued *
October 02, 2013	Lee K of NY Inc.	New York District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	Not Issued *
October 02, 2013	Rocklan Farm	New York District Office	Illegal Drug Residue	Not Issued *
October 01, 2013	Earl Wolfe Farms Inc	Cincinnati District Office	Illegal Drug Residue	Not Issued *
October 01, 2013	Poultry Products Company, Inc dba Poultry Products Northeast	New England District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	Not Issued *
September 20, 2013	Capillus LLC	Florida District Office	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
September 12, 2013	Dimitri Sirakoff	Center for Drug Evaluation and Research	Clinical Investigator	Not Issued *
September 03, 2013	Omid Nassim, M.D.	Center for Drug Evaluation and Research	Clinical Investigator	Not Issued *
August 21, 2013	Dolphin Intertrade Corporation	Florida District Office	Unapproved and Misbranded New Drugs	Not Issued *
August 09, 2013	Electro Medical, Inc	Dallas District Office	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
August 02, 2013	DNE Nutraceuticals Inc.	New Jersey District Office	CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated	Not Issued *
July 24, 2013	Northern Digital Inc.	Center for Devices and Radiological Health	Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded	Not Issued *
July 19, 2013	Farmer John Egg Enterprises, Inc.	San Francisco District Office	PHS Act/Shell Egg Regulation/Adulterated	Not Issued *