FDA 483 - BWXT Medical Ltd. - March 03, 2023

BWXT Medical Ltd in Kanata was inspected and received eight observations related to significant deficiencies in their manufacturing processes, quality control, and personnel training. The inspection revealed issues with process validation, sterility assurance, statistical procedures for testing, supplier qualification, discrepancy investigations, container testing, and test method validation, indicating a broad lack of control over critical aspects of drug product manufacturing. These findings suggest a high severity of non-compliance impacting product quality and safety.