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

An FDA inspection of Instituto Grifols, S.A. identified significant deficiencies in their quality control and complaint handling systems. The firm failed to adequately investigate customer complaints for Fibrin Sealant and did not thoroughly review unexplained discrepancies for Flebogamma, including issues with raw data traceability. Additionally, the inspection revealed unjustified deviations from production procedures, inadequate written procedures for production controls, and a failure to follow their stability testing program, particularly concerning out-of-specification results.