American Regent, Inc. – FDA 483, Apr 24, 2024

American Regent, Inc., a sterile drug manufacturer in Shirley, NY, was cited with seven observations during an FDA inspection. Deficiencies include inadequate aseptic processing air supply and environmental monitoring, inappropriate equipment design, and insufficient validation of aseptic processes. Additionally, the firm lacked proper computer system controls, failed to store drug products under appropriate temperature conditions, and had inadequate procedures for container closure integrity.