FDA 483 - Bionen S.r.l. - February 20, 2020

Bionen S.A.S. in Firenze, Italy, received two observations during an FDA inspection concerning the manufacturing of medical devices, specifically needle electrodes for Botox injection. The inspection revealed deficiencies in adequately validating the sensor assembly and pouch sealing processes, as well as failures in establishing adequate procedures for investigating and evaluating complaints for MDR reportability.