FDA 483 - Bausch & Lomb Incorporated - March 20, 2026

From March 12 to March 20, 2026, the FDA inspected the Bausch and Lomb Incorporated facility in Tampa, Florida, a manufacturer of sterile drug products. The inspection resulted in a Form 483 identifying several critical failures in quality control and manufacturing safety. Primary violations included the inadequate investigation of serious customer complaints involving foreign materials such as metal shards, glass-like particles, and black residue. Notably, the firm failed to file a required Field Alert Report after discovering Pseudomonas aeruginosa in a product container. Further observations highlighted significant lapses in sterility protocols. Staff were observed engaging in improper aseptic behaviors, such as moving too quickly in cleanrooms and mishandling sterile gloves. The facility also recorded over 250 instances of microbial and mold contamination in supposedly sterile areas but failed to perform thorough investigations or identify specific bacterial strains. Additionally, the inspection revealed deficiencies in material handling, including missing documentation for quarantined shipments and inventory storage errors that could lead to product mix-ups. These findings were issued under Section 704 of the Food, Drug, and Cosmetic Act. While the report is not a final determination of non-compliance, Bausch and Lomb is expected to respond with a comprehensive corrective action plan. This plan must address the root causes of contamination and improve documentation standards to ensure the safety and integrity of their sterile pharmaceutical products.