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Responding to PMDA Inspection Findings

Types of findings and their severity​

PMDA inspection findings are typically classified by severity:

Major finding (重大な指摘事項): A significant QMS deficiency that could affect device safety or quality. Major findings must be resolved before approval is issued (for pre-approval inspections). In routine inspections, major findings require a formal CAPA response and may trigger a follow-up inspection.

Minor finding (指摘事項): A QMS deficiency that does not immediately affect safety but represents a deviation from MO 169 requirements. Minor findings require a CAPA response but typically do not delay approval.

Observation (改善を要する事項): A suggestion for improvement rather than a finding of non-compliance. Responses are expected but are less formal.

Response timelines​

PMDA sets response deadlines for each finding in the inspection report. Typical timelines:

  • Initial response (CAPA plan): within 2–4 weeks of receiving the inspection report
  • CAPA implementation and evidence: within the period agreed with PMDA (varies 1–6 months depending on complexity)

Failure to respond within PMDA's timelines is treated seriously and can affect the approval outcome for pre-approval inspections.

CAPA commitments to PMDA​

Responses to PMDA findings must:

  • Acknowledge the finding clearly
  • Identify the root cause
  • Describe the corrective action taken or planned
  • Provide a timeline for completion
  • Describe how effectiveness will be verified

Vague or uncommitted responses are typically rejected by PMDA with a request for more specific information.

Re-inspection after significant findings​

Where major findings are identified, PMDA may require a re-inspection to verify that the CAPA has been effectively implemented. Plan for a re-inspection lead time of approximately 3–6 months after CAPA implementation.