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Jiangsu Shenli Medical Production Co., Ltd., a manufacturer of sterile and non-sterile syringes, failed to comply with FDA's Quality System Regulation (21 CFR Part 820) during an inspection conducted March 25-29, 2024. The firm lacked proper documentation and procedures for device design and development, particularly for bulk non-sterile Luer Lock syringes in multiple sizes (3 mL through 30 mL), and did not maintain adequate manufacturing controls to ensure their devices met specified design requirements. The company's responses submitted in April and May 2024 were found insufficient to address the investigator's observations, resulting in the devices being deemed adulterated under federal law.