FDA 483 - Catalent Ontario Limited - January 20, 2023

During an inspection conducted from January 16-20, 2023, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Catalent Ontario Limited, a non-sterile bulk drug manufacturer located in Windsor, N9C 3R5. The inspection identified a significant observation concerning the storage of drug product reserve samples. The primary issue noted was that the company's finished bulk drug product retain samples were not stored in an immediate container-closure system that mirrored the characteristics of the marketed product. Specifically, while finished bulk drug products are distributed to customers in a proprietary bag placed within a carton box, the corresponding retain samples were found to be stored in a proprietary bottle. This discrepancy in packaging systems for distributed product versus reserve samples fails to meet regulatory expectations for maintaining representative samples. The Form FDA 483 serves as an alert to management regarding these inspectional observations, which do not represent a final agency determination of compliance. Catalent Ontario Limited is required to respond by discussing their objections or outlining planned corrective actions for these findings. Addressing this observation is crucial for ensuring the integrity and representativeness of their drug product reserve samples, which are vital for quality control and regulatory compliance.