Ascent Pharmaceuticals Inc – FDA 483, Aug 9, 2024

Ascent Pharmaceuticals Inc. in Central Islip, NY, was inspected and cited for significant deficiencies across multiple areas of its drug manufacturing operations. Observations included inadequate cleaning of equipment, insufficient computer system controls and audit trail reviews, lack of routine equipment performance checks, and a failure to investigate unexplained batch discrepancies. These issues indicate a lack of control over manufacturing processes and data integrity.