FDA WARNING_LETTER - Bausch & Lomb Inc. - March 20, 2026

Bausch & Lomb Inc. received an FDA warning letter following an inspection conducted from March 12 to 20, 2026, at its Tampa, Florida facility. The letter details serious violations of Current Good Manufacturing Practice (CGMP) regulations under the Federal Food, Drug, and Cosmetic Act, specifically regarding the production of sterile prescription and over-the-counter drugs. Main issues identified include an inadequate environmental monitoring program that failed to address persistent microbiological contamination in sterile processing areas. The FDA also noted significant design flaws in manufacturing equipment that hindered proper airflow and sterile transfers. Furthermore, inspectors observed personnel exhibiting poor cleanroom behavior, such as improper disinfection and reaching over sterile containers. These deficiencies, combined with an ineffective quality control system, led the FDA to classify the company’s products as adulterated. To achieve compliance, Bausch & Lomb must engage independent experts to conduct a comprehensive review of their monitoring programs and facility designs. The company is required to perform detailed risk assessments for distributed products, test existing stock for safety, and submit a thorough remediation plan with specific timelines. The FDA has also requested a formal meeting to discuss the company’s corrective and preventive action strategies.