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.
Inspection findings Inspection Cases
- Failure to confirm adequacy of raw materials
- Risks associated with handling substances with unknown pharmacological activities and toxicities
- Overlooked risks to the quality of products due to insufficient CAPA
- Importance of thorough management of outsourced activities
- Improper recording
- Improper modification of records to align with instructions
- Mislabeling of the products caused by the violation of procedures
- Environmental monitoring in aseptic processing areas
- Handling of stability monitoring results
- Communication within the Organization (From the Manufacturing Floor to Management)
- Communication within the Organization (From Management to the Manufacturing Floor)
- Development of a Risk-Based Validation Plan
