FDA 483 - Grifols Biologicals LLC - May 03, 2024

An FDA inspection of Grifols Biologicals LLC in Los Angeles, CA, a biologics and plasma derivatives facility, revealed significant deficiencies across multiple areas. Observations included inadequate environmental monitoring in aseptic processing areas, failure to follow complaint handling procedures for drug products, and poor maintenance of manufacturing buildings. These issues indicate a lack of control over critical manufacturing processes and quality systems.