FDA EIR - Patheon Italia S.p.A. - September 29, 2023

An FDA inspection of Patheon Italia S.p.A., a biological drug contract manufacturer in Monza, Italy, was conducted from September 21-29, 2023. This routine, full inspection covered the firm’s Quality, Materials, Production, and Lab Control systems, focusing on vaccine manufacturing. The inspection was performed under compliance program #7345.848 for Biological Drug Products. The inspection concluded with one formal observation documented on a Form FDA483, primarily citing a failure to follow procedures for warehousing drug products. Specifically, the firm's inventory management system showed discrepancies with the physical inventory of raw materials in the dispensing area and finished product in storage, violating 21 CFR 211.142. Additionally, several verbal observations were discussed during the close-out meeting. These included incomplete documentation in written testing and maintenance records, a lack of good documentation practices for supplier audit assessment, and unclear specifications for alert and action limits in water system procedures. Management, represented by Ms. Annalisa Barile, Vice President and General Manager, acknowledged the FDA483 observation and committed to providing a written response to the agency within fifteen business days. This indicates the need for the firm to implement corrective actions to ensure accurate inventory control and improve documentation practices.