FDA 483 - Instituto Grifols, S.A. - November 17, 2023

Instituto Grifols, S.A. in Parets Del Valles, Barcelona, Spain, was cited for significant deficiencies in its quality control and complaint handling systems. The inspection revealed inadequate investigations into product quality complaints and unexplained discrepancies, as well as failures in following and establishing proper procedures for production, process controls, and stability testing. These issues indicate a systemic breakdown in ensuring drug product quality and integrity.