FDA 483 - Pointcore Supply Chain Service LLC - June 26, 2025

Pointcore Supply Chain Service LLC in Peoria, IL was inspected, revealing significant deficiencies in its quality system. The inspection found a pervasive lack of established and implemented procedures for critical quality functions, including quality plans, CAPA, complaint handling, management review, quality audits, and design change. Management also demonstrated a lack of awareness regarding the firm's quality policy and the designated management representative lacked necessary training, indicating a fundamental breakdown in quality system oversight for their Class II medical devices.