FDA 483 - Biofortuna Limited - February 01, 2019

An FDA inspection of Biofortuna Limited, a non-sterile drug product manufacturer in Bromborough, UK, revealed significant deficiencies across multiple areas of its quality system. Observations included inadequate employee training in GMP, insufficient bioburden and process controls, poor raw material acceptance procedures, and inadequately qualified and maintained facilities and equipment. Additionally, the firm lacked proper written procedures for manufacturing activities and failed to establish a required Supplier Technical Agreement for environmental monitoring services.