FDA 483 - ALCON-COUVREUR N.V. - November 05, 2021

Alcon-Couvreur in Puurs, Belgium, was cited with three observations during an FDA inspection from October 28 to November 5, 2021. The firm demonstrated deficiencies in establishing adequate production and process controls, including poor aseptic technique, an inadequate smoke study, and insufficient visual inspector training. Furthermore, issues were noted with the revalidation of a fill line and the maintenance of manufacturing equipment, specifically discolored rods and multiple water system leaks.