The Japanese authority PMDA (Pharmaceutical and Medical Device Agency) which instituted a Warning Letter system in September 2025 has issued its first Warning Letter on 1 September 2026 to a contract manufacturer of generic pharmaceuticals in Japan’s Wakayama prefecture.
The new WL system represents a strengthening of government authority in conducting inspections (including district inspections).
Similar to the US, PMDA Warning Letters contain the name of the company, its address, items of non-conformity and the short history related to the observation.
In the PMDA website you can find:
- All company names receiving PMDA inspections since September 2025.
- All Warning Letters issued since September 2025.
In the first Warning Letter, two non-conformities are cited and three instances of inadequate handling of stability testing lead the list:
- When a stability result became OOS, but it was fraudulently reported to the Marketing Authorization Holder (MAH) to have a value within specifications.
- Some stability test methods were not performed, but results were recorded as if they were performed and were within specifications.
- A root cause of OOS was not investigated and instead, results using a different reference sample were recorded.
The PMDA noted that administrative measures should follow.
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