PMDA · Inspection Cases

PMDA inspection findings (ORANGE Letter)

The English editions of the GMP inspection findings (ORANGE Letter) and the GMP/GCTP annual reports published by Japan's Pharmaceuticals and Medical Devices Agency (PMDA). Rather than naming companies, an ORANGE Letter explains the background, risk, and check points of deficiency types found repeatedly in inspections — inadequate records, weak CAPA, aseptic environmental monitoring, and so on — as anonymised cases. Each document links directly to the official PDF. The English edition may lag the Japanese original; check the official source for the latest status.