FDA 483 - PCAS Finland Oy - June 07, 2024

An FDA inspection of PCAS Finland Oy, an API manufacturer in Turku, Finland, revealed significant deficiencies in quality control and facility maintenance. The firm failed to investigate unknown impurities in its Active Pharmaceutical Ingredient (API) using an in-house analytical method and lacked established maintenance procedures for critical manufacturing equipment. Additionally, the inspection found poor repair and maintenance of manufacturing spaces and equipment in bioburden-controlled areas, including holes in exhaust vents and compromised air intake vents.