FDA 483 - Circuit Works Corporation - February 15, 2022

Circuit Works Corporation, a medical device contract manufacturer in Waukegan, IL, was inspected and received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in their quality system, including repeat observations from a 2017 inspection concerning corrective and preventive actions, process validation, and internal audit independence. The firm also lacked established procedures for in-process product acceptance.