FDA 483 - Allergan Sales, LLC - November 07, 2025

The FDA conducted an inspection of Allergan Sales, LLC (BLI) in Irvine, CA, from October 27 to November 7, 2025, issuing a Form 483 that outlines several significant observations regarding their drug substance manufacturing facility. The findings primarily center on inadequate microbial control and quality system deficiencies, indicating potential non-compliance with Current Good Manufacturing Practices (cGMP). Major issues identified include an insufficiently designed manufacturing process and facility unable to adequately mitigate contamination risks or detect contaminants during Process Performance Qualification (PPQ) campaigns. This was exacerbated by inadequate in-process microbial testing, facility design flaws concerning pressure differentials, and deficient personnel movement procedures that failed to prevent cross-contamination from fermentation areas. The inspection also cited shortcomings in environmental monitoring, specifically regarding an inadequate anaerobic monitoring program, poor control of mold in classified areas, and the absence of appropriate alert/action limits for mold. Cleaning, disinfection, and decontamination procedures were deemed insufficient, lacking comprehensive surface coverage in validation studies and neglecting to document validated contact times. Additionally, Allergan performed substantial architectural and mechanical modifications to the manufacturing suite that deviated from the conditions under which PPQ was initially conducted. Finally, various risk assessments, including those for environmental monitoring and water systems, were found to be deficient, failing to adequately evaluate microbial and cross-contamination risks, facility changes, and adverse utility monitoring trends. Allergan Sales, LLC is required to submit a comprehensive response detailing corrective and preventive actions to address these critical observations.