MFDS Inspections and Administrative Actions
Types of MFDS inspections
| Inspection type | Description |
|---|---|
| GMP certification inspection | Initial KGMP certification for domestic manufacturers |
| Periodic re-inspection | KGMP certificate renewal (~every 3 years) |
| Surveillance inspection | Routine, unannounced conducted during certificate validity period monitoring |
| For-cause inspection | Triggered by adverse events, complaints, or intelligence |
| Market surveillance inspection | Distributors, retail; includes product sampling |
Administrative actions after inspection
| Finding | Possible action |
|---|---|
| Minor nonconformity | CAPA required; certificate maintained |
| Major nonconformity | CAPA required; certificate suspended until resolved |
| Critical finding / fraud | Certificate revoked; products may be recalled |
| Criminal violation | Case referred for prosecution |
Related pages
Administrative actions after inspection
CAPA submission timeframe: For major nonconformities, manufacturers must submit a detailed CAPA plan within 30 days of inspection report receipt. Implementation timeline depends on nonconformity severity but typically ranges from 60–180 days.