Ex-PMDA Inspector Urges Improvements in Japanese Inspection Systems after GMP Scandals

Ex-PMDA Inspector Shingo Sakurai Japanese generic majors Kobayashi Kako and Nichi-Iko Pharmaceutical incurred administrative sanctions in February and March, respectively, due to GMP violations over the years. Why didn’t inspectors identify these problems sooner? Shingo Sakurai, a former inspector with...read more