FDA 483 - Element Materials Technology Boston - Acton Inc. - January 15, 2019

Microbiology Research Associates, Inc., a control testing laboratory in Acton, MA, was cited for failing to follow established laboratory control mechanisms. Specifically, the firm did not initiate an out-of-specification investigation or notify a client when a drug sample failed endotoxin testing specifications. This indicates a lapse in quality control procedures for drug product testing.