FDA 483 - Instituto Grifols, S.A.

Instituto Grifols, S.A., a biologic plasma fractionation and finished drug manufacturer in Parets del Valles, Spain, was cited for two significant observations. The firm's Quality Unit lacked authority to properly investigate recurring power loss issues affecting critical systems and products, failing to link deviations or implement corrective actions. Additionally, investigations into a serious adverse event, including a patient death associated with an immunoglobulin product, were not promptly initiated or completed.