FDA 483 - Alcon Singapore Manufacturing Pte Ltd. - September 08, 2023

Alcon Singapore Manufacturing Pte Ltd. was inspected by the FDA from September 4-8, 2023, revealing significant deficiencies in aseptic processing, environmental monitoring, laboratory controls, and complaint investigations. The observations indicate a lack of adherence to procedures designed to prevent microbiological contamination and ensure drug product quality and purity. These issues suggest a moderate to severe risk to product sterility and quality.