FDA 483 - Bausch & Lomb Incorporated - February 27, 2025

An FDA inspection of Bausch & Lomb Incorporated in Greenville, SC, a sterile drug manufacturer, revealed significant deficiencies in preventing microbiological contamination, including inadequate sterilization rationales, flawed media fills, and compromised ISO-5 air spaces. The inspection also cited issues with drug product specifications lacking sampling plans and equipment maintenance procedures for raw ingredient dispensing scales. These observations indicate a need for improved controls to ensure the sterility and quality of ophthalmic drug products.