ZACROS CORPORATION – FDA 483, Jan 23, 2023

An FDA inspection of Fujimori Kogyo Co., Ltd. in Bunkyo, Tokyo, Japan, revealed a significant deficiency in the firm's quality system. The company failed to establish procedures for design control, specifically regarding the T-TAS 01 System, where critical design documentation and source code for an instrument component were held by a contractor and not integrated into the firm's Design History File. This indicates a fundamental breakdown in managing medical device design processes.