WISE PLASTICS TECHNOLOGIES INC – FDA 483, May 19, 2023

An FDA inspection of WISE PLASTICS TECHNOLOGIES INC in West Chicago, IL, a contract manufacturer of medical devices, revealed significant deficiencies in their quality management system. Observations included inadequate corrective and preventive action procedures, insufficient software validation for their quality system, and a quality plan that fails to reference relevant FDA regulations like 21 CFR 820. These issues indicate a lack of robust controls for managing product quality and regulatory compliance.