FDA EIR - Bausch & Lomb Incorporated - February 25, 2016

An FDA inspection of Bausch & Lomb, Inc. in Tampa, FL, was conducted from February 8 to February 25, 2016. This inspection served as an abbreviated cGMP review, a pre-approval inspection for NDA 207795 (Latanoprostene Bunod 0.024% Topical Ophthalmic Solution), and a follow-up on unapproved drugs, adhering to drug manufacturing and pre-approval inspection guidelines. The inspection identified significant concerns, resulting in an FDA-483 with several observations. Key issues included incomplete nonconformance investigations for particulate matter and environmental monitoring, lacking scientific justification. Environmental monitoring samples were improperly taken under non-dynamic conditions, and hold time studies for cleaned equipment were deemed inadequate. Furthermore, in-process controls were not adequately selected to ensure production is consistently controlled. A systemic particulate issue was noted on aseptic filling lines, suggesting deficiencies in facility design, equipment, maintenance, and airflow controls. The firm's quality system was found ineffective in identifying, resolving, and preventing these quality issues. Previous inspection findings, such as non-compliance with supplier audit procedures, remained unaddressed and contributed to the current particulate findings. As a result, a withhold recommendation was issued for NDA 207795 due to these unacceptable cGMP conditions and an ineffective quality system. Bausch & Lomb's management committed to addressing the observations to achieve sufficient control over manufacturing operations and prevent future quality issues.