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Becton, Dickinson, and Company/CareFusion 303, Inc. was found to be manufacturing adulterated Pyxis Medication Management System devices (including MedStation ES, ES Anesthesia, and MedBank models) in violation of current good manufacturing practice requirements under 21 CFR Part 820. The FDA inspection in May 2024 identified failures to establish and implement corrective and preventive action procedures, with the company maintaining 544 open software defect tickets, of which 111 were classified as causing catastrophic or severe patient harm. The company submitted responses to the FDA's inspection observations in June, July, and September 2024.