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

An FDA inspection of PURIBLOOD MEDICAL CO., LTD, a medical device manufacturer in Baoshan Township, Taiwan, revealed significant deficiencies in its quality system. The firm failed to adequately establish procedures for corrective and preventive actions, including root cause analysis and verification of effectiveness. Additionally, complaint handling procedures were found to be inadequate, and controls over purchased products and services were not properly defined.