FDA 483 - Physician Software Systems LLC - June 06, 2022

An FDA inspection of Physician Software Systems LLC in Lisle, IL, from May 31 to June 6, 2022, revealed significant quality system deficiencies related to their Class II medical device, PhySoft AMS. The firm failed to adequately document corrective and preventive actions, maintain a device master record, establish device history record procedures, and properly evaluate all complaints. These issues indicate a lack of robust control over their anemia management software's quality processes.