PHC Corporation – FDA 483, Dec 18, 2017

An FDA inspection of Panasonic Healthcare Co., Ltd. in Wakimachi, Japan, revealed significant deficiencies in the firm's quality system for blood glucose monitors. Observations included inadequate design controls, specifically concerning the device owner's review and approval of design verification protocols, risk analyses, and design transfer activities. Additionally, the inspection cited issues with process validation for meter production, noting insufficient sample sizes and a lack of robust repeatability testing.