FDA 483 - PURIBLOOD MEDICAL CO., LTD - March 14, 2025

An FDA inspection of PURIBLOOD MEDICAL CO., LTD in Baoshan Township, Taiwan, revealed significant deficiencies in the firm's quality system. Observations included inadequate procedures for corrective and preventive actions, particularly regarding root cause analysis and effectiveness verification. Additionally, the firm failed to adequately establish procedures for complaint handling and ensuring purchased products and services conform to specified requirements.