What happened
FDA states that its March 12–20, 2026 inspection of Bausch & Lomb’s Tampa drug manufacturing facility identified significant CGMP violations involving sterile prescription and OTC products. Environmental and personnel monitoring did not sufficiently cover significant locations, procedures were inadequate, and cracked media could not adequately support growth of recovered contamination. From 2023 to 2025, the firm routinely recovered out-of-limit microorganisms in ISO 5 areas, including gram-negative organisms associated with water sources, but continued production without adequate CAPA. FDA also cited inadequate investigations of microbiological departures and adverse trends, insufficient microorganism identification, RABS and barrier-design deficiencies, and smoke studies that did not sufficiently demonstrate unidirectional airflow. Operators were repeatedly observed using poor aseptic techniques during filling. Media fills were substantially smaller than commercial batches and did not adequately represent contamination risks; a July 2025 media fill failed with fungal and spore-forming bacterial contamination. FDA further stated that management oversight was ineffective and the quality unit lacked sufficient authority or implementation of its responsibilities.
Why it matters
FDA states that exposed sterile products in ISO 5 environments are vulnerable to contamination when operations are not well designed and diligently controlled. Persistent microbial recoveries, inadequate investigations, poor operator practices, deficient airflow studies, and unrepresentative media fills may undermine assurance that aseptic processes remain controlled and products remain sterile. The cited quality-system weaknesses may also hinder timely detection, investigation, remediation, and prevention of recurring contamination hazards. FDA specifically noted that finished-product sterility testing cannot alone justify batch release.
Key topics: Persistent out-of-limit microbial contamination in ISO 5 environments, Poor aseptic technique, line design, and unidirectional airflow protection, Inadequate media fills, investigations, CAPA, and quality unit oversight