FDA 483 - Patheon Italia S.p.A. - September 05, 2023

Patheon Italia S.p.A. in Monza, Italy, a drug product manufacturer, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate preventative maintenance on a sterile fill line, insufficient procedures for material allocation during performance qualification, and aseptic process simulations that did not accurately reflect production. Additionally, the cleaning and disinfection of the RABS aseptic processing area were found to be inadequate.