FDA 483 - Cilag AG - June 16, 2025

Cilag AG in Schaffhausen, Switzerland, received a Form 483 for significant deficiencies in equipment maintenance, facility design, and aseptic processing controls during drug product manufacturing. Observations included issues with vial capping, sterile assembly design, surface integrity, environmental sealants, and critical surface contamination during fill line setup. Additionally, the firm failed to revalidate critical hold times in SOPs and lacked adequate validation for sterilization equipment.