FDA 483 - Cilag AG - September 23, 2024

Cilag AG, a drug product manufacturer in Schaffhausen, Switzerland, was cited for significant deficiencies during an FDA inspection. Observations included inadequate procedures for preventing microbiological contamination of sterile drug products, insufficient environmental monitoring in aseptic processing areas, and failures in assuring drug product quality through proper visual inspection and equipment maintenance. These issues indicate a lack of control over critical manufacturing processes and quality systems.