FDA 483 - Biofac A/S - September 23, 2022

Biofac A/S, a manufacturer in Kastrup Copenhagen, Denmark, was cited for significant deficiencies across its quality management system, laboratory controls, and equipment validation. The inspection revealed failures in performing required quality reviews, inadequate computer system controls, unscientific test procedures, and a lack of thorough investigation into discrepancies and out-of-specification results. Additionally, the firm used unvalidated equipment for manufacturing GMP products, indicating a broad breakdown in quality assurance.