FDA 483 - PLZ Corp. - June 07, 2019

K-G Spray-Pak Inc. in Mississauga, an OTC drug manufacturer, was cited for significant deficiencies in its laboratory control and facilities and equipment systems. The inspection revealed issues with data integrity, including unreviewed audit trails and backups, inadequate computer system security procedures, and missing laboratory records. Additionally, the firm failed to properly qualify chromatographic software and perform routine calibration of mechanical equipment.