On-site inspection report (EIR) from U.S. FDA issued in May 23, 2017 was received.

From January 16 to 20, 2017, we received the on-site audit from U.S. FDA for five days. During the audit, the inspectors strictly reviewed systems of workshop, quality control and assurance, warehousing, water, equipment and facilities. Eventually, 7 observations were made. All corrective actions were completed and the written reports were submitted to FDA before May, 2017.

We made fully preparation for this audit and it not only proves our ability to accept the inspection from authorization party but also gives us the opportunity to improve our quality management level as well as enterprise management level. Through this audit, it largely builds our confidence to produce high quality product and enter into advanced international market in the future.