FDA 483 - Patheon Italia S.p.A. - September 03, 2021

During an inspection conducted from August 30 to September 3, 2021, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Patheon Italia S.p.A. at its Monza, Italy facility, a manufacturer of drug products. The primary observation highlighted that procedures designed to prevent microbiological contamination of sterile drug products were not consistently followed.

Specifically, the FDA investigators observed deficiencies in aseptic techniques within the Sterile Area (b) (4) Filling Line Suite during the manufacture of (b) (4) Drug Product. Issues included operators designated for sterile (First-Air) and non-sterile (Second-Air) tasks interchangeably handling items such as bottles, wipes, and equipment during pre-fill setup. Additionally, First-Air operators were seen handling non-sterile items, like the exterior of bags and electrical wires, immediately prior to engaging with sterile components of the filling line. The existing Standard Operating Procedure (SOP-000030521) for the filling line did not provide adequate guidance on maintaining First-Air integrity.

This FDA Form 483 serves as an official communication of inspectional observations, indicating areas where the firm's practices deviate from regulatory expectations for sterile manufacturing. Patheon Italia S.p.A. is required to address these observations by developing and implementing appropriate corrective and preventive actions to ensure compliance and prevent recurrence.