FDA 483 - Merck Serono S.p.A. - May 10, 2023

An FDA inspection of Merck Serono S.p.A. - (MS-Bari), a drug product manufacturer in Bari, Italy, revealed multiple deficiencies in their manufacturing operations. Observations included issues with aseptic processing design, inadequate control strategies for product and excipients, and unvalidated sterilization processes. Further concerns were raised regarding inadequate equipment maintenance and insufficient cleaning and disinfection practices in aseptic areas.