FDA 483 - DeGen Medical Inc. - August 29, 2019

An FDA inspection of DeGen Medical Inc. in Florence, SC, a specification developer, revealed significant deficiencies in their quality system. The firm failed to adequately investigate device complaints, specifically regarding a rod holder that broke during surgery. Additionally, procedures for controlling nonconforming products were not adequately established, as evidenced by uninvestigated incorrect screws and a lack of documented corrective and preventive actions.