FDA 483 - KOWA CO. LTD. CHOFU - July 05, 2018

KOWA CO. LTD. CHOFU, a medical device manufacturer in Chofu, Tokyo, Japan, was inspected by the FDA. The inspection resulted in two observations concerning the firm's quality system. Specifically, the firm failed to establish acceptance criteria for validation activities related to a firmware change for a Class 2 fundus camera and lacked established procedures for maintaining device history records.