Cilag AG – FDA 483, Jun 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.
ID · 537b1473-d6a2-423b-ab58-5fa704f72354
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