FDA 483 - INVENTUS POWER, INC - March 28, 2023

An FDA inspection of INVENTUS POWER, INC in Woodridge, IL, revealed significant deficiencies in the firm's corrective and preventive action (CAPA) system. The company failed to adequately document CAPA activities and results, including corrective action plans and verification of effectiveness checks. Additionally, procedures for establishing and managing CAPAs were found to be inadequately defined, lacking descriptions for root cause categories and processes for handling missed due dates.