FDA 483 - Immunodiagnostic Systems Sa - September 07, 2023

An FDA inspection of Immunodiagnostic Systems Sa in Liege, Belgium, revealed significant deficiencies in their corrective and preventive action (CAPA) procedures. The firm's CAPA SOPs did not require effectiveness checks, leading to multiple CAPA reports where effectiveness was either not assessed or only a correction was listed. This indicates a critical breakdown in ensuring the long-term efficacy of corrective actions for product quality issues.