Prometic Bioproduction Inc. – FDA 483, May 22, 2026

An FDA inspection of Prometic Bioproduction Inc. in Laval, a drug substance manufacturer, revealed significant deficiencies in material storage and facility maintenance. The firm's inventory management system failed to accurately track and segregate manufacturing materials, including expired and quarantined items, and physical locations did not match records. Additionally, the building used for material storage was inadequately maintained, with observations of damaged ductwork and water leakage from air handling units.