FDA 483 - AIAC International Pharma, LLC - November 07, 2025

AIAC International Pharma, LLC, a contract manufacturer in Arecibo, PR, was inspected from November 3-7, 2025. The inspection revealed a critical failure to establish adequate written procedures for production and process controls, specifically concerning the staging and tracking of materials during manufacturing operations. This deficiency resulted in inadequate material identification and control, leading to repeated incidents of incorrect material usage and demonstrating the ineffectiveness of prior corrective actions.