FDA 483 - Patheon Italia S.p.A. - September 29, 2023

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from September 21-29, 2023, Patheon Italia S.p.A., a biological drug manufacturer located in Monza, Italy, received a Form FDA 483. This document outlines objectionable conditions observed during the inspection, issued under the authority of Section 704(b) of the Federal Food, Drug, and Cosmetic Act. The primary observation noted a failure to follow established procedures for the warehousing of drug products. Specifically, the company's written procedures for tracking material storage and movement, including dispensing to manufacturing and finished product storage, were not consistently adhered to. Instances of inventory discrepancies were identified. For example, on September 22, 2023, a dispensing location's inventory in the tracking system did not match the physical items present. Similarly, on September 28, 2023, a batch of finished product was physically retrieved, yet the tracking system incorrectly indicated it was still in storage. These observations highlight a lapse in inventory control and adherence to internal standard operating procedures. While a Form FDA 483 does not represent a final compliance determination, Patheon Italia S.p.A. is expected to promptly evaluate these findings and submit a comprehensive response detailing its proposed corrective actions to address the identified issues and ensure compliance with regulatory standards.