FDA 483 - Contract Pharmaceuticals Limited Canada - November 03, 2023

An FDA inspection of Contract Pharmaceuticals Limited Canada in Mississauga, Canada, revealed a significant lapse in quality control procedures. The firm failed to thoroughly investigate the recovery of a highly pathogenic microorganism, Brucella melitensis, during environmental monitoring of a production area. This indicates a serious deficiency in their incident reporting and investigation processes, potentially compromising product safety.