FDA 483 - BioConnection B.V. - March 04, 2020

An FDA inspection of Bioconnection BV, a contract drug manufacturer in Oss, Netherlands, revealed significant deficiencies in the production of sterile drug products, specifically Ruconest. The firm lacked adequate validation for aseptic and sterilization processes, failed to establish written procedures for preventing microbiological contamination, and exhibited shortcomings in environmental monitoring, cleaning, quality control unit responsibilities, in-process controls, and discrepancy investigations. These issues indicate a critical lack of control over sterile manufacturing operations.