FDA 483 - Avery Dennison Belgie BV - October 23, 2023

An FDA inspection of Avery Dennison Belgie BV, a medical device manufacturer in Turnhout, Antwerpen, Belgium, revealed significant deficiencies in their quality system. Observations included inadequate procedures for process changes and monitoring, as well as shortcomings in the design validation for their Incise Surgical Drape with CHG. These issues suggest a need for improved controls over manufacturing processes and product development.