FDA 483 - Lifeaire Systems - August 29, 2023

An FDA inspection of Lifeaire Systems, a specification developer in Allentown, PA, revealed significant deficiencies in their quality management system. The firm failed to adequately establish complaint handling procedures, ensure supplier compliance through evaluations, and conduct required management reviews or quality audits. These issues indicate a systemic lack of oversight and adherence to quality system requirements for their Class II medical devices.