FDA 483 - MSD Ireland (Carlow) - April 01, 2025

MSD Ireland (Carlow), a biological drug manufacturer, was inspected and cited for three observations. The inspection revealed deficiencies in environmental monitoring in aseptic processing areas, a failure to thoroughly investigate unexplained discrepancies, and inadequate procedures for preventing microbiological contamination of sterile drug products, particularly regarding retesting protocols. These issues impact the quality control and assurance of biological drug products like Gardasil 9 and Capvaxive.