FDA 483 - Unisis Corp. - May 18, 2023

Unisis Corp., a medical device manufacturer in Koshigaya, Saitama, Japan, received a Form FDA 483 with five observations during an inspection from May 15-18, 2023. The inspection revealed significant deficiencies in the firm's quality system, including a lack of established procedures for design control, corrective and preventive actions, in-process product acceptance, and purchasing controls. Additionally, the firm failed to ensure device history records conformed to master records and did not require contract manufacturers to be registered or listed with the U.S. FDA.