FDA 483 - Pillar Biosciences Inc. - September 16, 2025

An FDA inspection of Pillar Biosciences Inc. in Natick, MA, revealed significant deficiencies in their corrective and preventive action (CAPA) procedures. The firm failed to consistently meet CAPA timeline requirements, adequately document extensions, and ensure consistency between its CAPA-related standard operating procedures. These issues indicate a breakdown in the firm's quality system regarding corrective and preventive actions.