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Jiangsu Caina Medical Co., Ltd manufactures sterile medical devices including Luer Lock Syringes without Needles and Enteral Syringes, which were found to be adulterated due to non-conformity with FDA's Quality System Regulation (21 CFR Part 820). The company failed to adequately establish and maintain corrective and preventive action (CAPA) procedures, specifically failing to analyze quality data sources to identify existing and potential causes of nonconforming products and other quality problems. The violations were identified during an FDA inspection conducted March 11-23, 2024, and the company submitted three responses between April and June 2024 that did not adequately address the investigator's observations.