FDA 483 - Terumo BCT Ltd - January 19, 2023

During an FDA inspection, Terumo BCT Ltd, a manufacturer in Larne, United Kingdom, was cited for inadequate procedures related to validated processes. The firm failed to adequately establish and document procedures for monitoring and controlling process parameters, specifically concerning unplanned maintenance and equipment repairs for sterilization equipment. This indicates deficiencies in their quality system controls for process validation and equipment management.