FDA 483 - Sanofi S.r.l. - February 02, 2023

Sanofi S.r.l., a medical device manufacturer in Anagni, Italy, received two observations during an FDA inspection. The firm was cited for inadequate procedures regarding corrective and preventive actions, specifically concerning root cause investigations and risk assessment for proposed actions. Additionally, the inspection found deficiencies in the firm's complaint handling system, including a failure to maintain records of adverse event complaints and an incomplete complaint handling procedure.