FDA 483 - Delpharm Montreal Inc. - September 01, 2023

Delpharm Montreal Inc. in Pointe-Claire, a drug manufacturer, received a Form 483 with four observations related to significant quality control and data integrity issues. The inspection revealed deficiencies in salvaging operations for contaminated drug products, inadequate computer system controls and audit trails, and a lack of routine maintenance for electronic equipment. Additionally, the firm failed to contemporaneously document laboratory control mechanisms.