Catalent Ontario Limited – FDA 483, May 2, 2025

Catalent Ontario Limited, a human and veterinary drug product manufacturer, was cited for significant quality control deficiencies during an FDA inspection. Observations included failures to thoroughly investigate discrepancies and batch failures, inadequate equipment cleaning and maintenance leading to contamination, and poorly designed equipment. Additionally, master production records were incomplete, and written procedures for production and process controls, such as hand hygiene, were found to be insufficient.