FDA 483 - E-Z-EM Canada, Inc - October 20, 2023

E-Z-EM Canada, Inc., a drug product manufacturer in Anjou, was cited for significant quality control failures during an FDA inspection. Observations included the quality control unit's failure to detect and investigate tank damage that could contaminate drug products, and a failure to thoroughly investigate numerous customer complaints regarding product contamination. These issues indicate a lack of robust quality system procedures and follow-through.