FDA 483 - Physician Software Systems LLC - June 06, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · c3fc4024-8c35-431d-b2d4-edbc5bb8a1f2