FDA 483 - Pillar5 Pharma Inc. - February 07, 2025

Pillar5 Pharma Inc., a contract manufacturer in Arnprior, was cited for significant deficiencies in its aseptic processing, quality control, and laboratory operations. The inspection revealed inadequate validation of aseptic processes, poor disinfectant efficacy studies, and failures in thoroughly investigating discrepancies and maintaining stability programs. These issues raise concerns about the sterility assurance and overall quality of drug products manufactured by the firm.