FDA 483 - ID Biomedical Corporation of Quebec - May 20, 2022

ID Biomedical Corporation of Quebec, a licensed biological drug manufacturer, was inspected by the FDA from May 12-20, 2022. The inspection revealed significant deficiencies in quality control, complaint handling, aseptic processing, and preventative maintenance. Issues included inadequate investigations into missing data, incomplete complaint records, and procedures insufficient to prevent microbial contamination of sterile drug products.