FDA WARNING_LETTER - EIKEN CHEMICAL CO., LTD. NOGI PLANT - November 09, 2012

An FDA inspection of Eiken Chemical Co. in Tochigi, Japan, from November 8-9, 2012, revealed significant violations concerning its fecal occult blood testing devices. The devices were found to be adulterated under section 501(f)(1)(B) of the Act because the firm lacked an approved premarket approval (PMA) application (section 515(a)) or an investigational device exemption (section 520(g)). Additionally, the devices were misbranded under section 502(o) for failure to submit a 510(k) premarket notification, as required by section 510(k) of the Act. The letter also cited nonconformances with Quality System regulation (21 CFR Part 820), specifically a failure to adequately establish and maintain procedures for validating device design (21 CFR 820.30(g)), evidenced by inadequate risk assessment for hemoglobin deterioration. Furthermore, the firm failed to adequately review, evaluate, and investigate complaints (21 CFR 820.198(c)), with numerous uninvestigated service call complaints. Eiken Chemical Co. must provide a written response within fifteen business days detailing corrective actions, prevention plans, and a timetable for implementation, including documentation and translations if not in English. Failure to address these issues could impact federal contracts and indicates systemic quality management problems.