FDAnews
www.fdanews.com/articles/123205-fda-abbott-molecular-failed-to-control-nonconformities

FDA: Abbott Molecular Failed to Control Nonconformities

December 25, 2009
Abbott Molecular’s failure to control nonconforming devices and implement complete procedures for accepting or rejecting finished product resulted in a warning letter. Abbott has taken steps to address the issues in the letter, Don Braakman, director of public affairs for Abbott’s diagnostics division, said. The company is discussing those actions with the FDA to determine what the agency wants, he added.
The GMP Letter