FDA 483 - Bausch & Lomb, Inc. - November 22, 2024

An FDA inspection of Bausch & Lomb, Inc. in Manchester, MO, revealed significant deficiencies in their quality system for medical instrument manufacturing. The firm failed to adequately establish procedures for finished device acceptance, leading to the release of non-conforming lots without proper control or evaluation. Additionally, the company lacked adequate corrective and preventive action procedures, failing to investigate recurring nonconformities and implement necessary changes following customer complaints.