FDA 483 - Sooil Development Co., Ltd. - January 23, 2020

An FDA inspection of Soci. Development Co., Ltd. in Gyeonggi-do, Gyeonggi, Korea, identified eight observations related to inadequate procedures across various quality system elements. The firm failed to establish adequate procedures for management review, quality audits, corrective and preventive actions, MDRs, calibration, environmental controls, supplier management, and training. These findings indicate significant deficiencies in the firm's quality management system.