FDA 483 - Bionet Co., Ltd. - February 18, 2019

During an inspection from February 18-21, 2019, Pionet Co. Ltd. was cited for inadequate establishment and implementation of corrective and preventive action (CAPA) procedures. Specifically, the firm's CAPA procedure was not adequately implemented, as nonconformities were not consistently reviewed as inputs into the system. This indicates a significant lapse in a fundamental quality system process.