FDA issues warning letter to Bausch & Lomb over aseptic processing concerns

FDA sent a warning letter to Bausch & Lomb after inspectors reviewed the company’s response to earlier observations at its Florida plant. The agency said the response did not demonstrate a commitment to implement significant design remediations.

Inspectors noted several deficiencies, including the use of phones in the aseptic processing area and inadequate practices to prevent contamination. They concluded the site lacks an effective quality management system for sterile prescription and over‑the‑counter drug production.

Bausch & Lomb replied that the letter does not require a halt to operations or a product recall and expressed confidence in the safety of its products, noting ongoing investments in improvements. The FDA, however, indicated the company’s plan failed to address how it will ensure adequate aseptic processing.