FDA 483 - Instituto Grifols, S.A. - November 17, 2023
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · aa26f7fe-87f5-4896-8bf9-06b32f81d0aa