FDA 483 - Fermion Oy

An FDA inspection of Fermion Oy, Espoo Plant, a contract testing laboratory, revealed significant data integrity issues related to LC-MS equipment, including the ability to delete data without audit trail capture, unreviewed electronic data, and inadequate data backup. The inspection also cited a lack of change control for work instructions and an ineffective CAPA for previously identified data integrity problems. These findings indicate serious deficiencies in the firm's quality management system.