FDA 483 - Alcon Research LLC - August 30, 2024

Alcon Research LLC, a sterile drug manufacturer in Fort Worth, TX, received a Form 483 with three observations. The inspection revealed deficiencies in facility maintenance, including structural damage and rust, as well as inadequate laboratory controls for sterility testing. Additionally, the firm lacked sufficient systems and processes to comply with Drug Supply Chain Security Act (DSCSA) verification and recordkeeping requirements.