FDA 483 - BWXT Medical Ltd - February 23, 2024

BWXT Medical Ltd, a radiochemicals API manufacturer in Vancouver, British Columbia, was cited for inadequate procedures to ensure correct labeling of API products. The inspection revealed repeated instances of erroneously pre-printed vial labels, attributed to human error and a quality control unit's failure to detail standard operating procedures sufficiently. This indicates a significant issue with label control and quality assurance processes.