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Responding to MFDS Inspection Findings

Response process​

  1. Acknowledge nonconformities in writing within the specified timeframe
  2. Submit a CAPA plan — identifying root cause and corrective actions
  3. Implement corrective actions
  4. Submit evidence of implementation to MFDS (records, revised procedures, training records)
  5. MFDS reviews and determines if nonconformities are adequately closed

CAPA quality and expectations​

MFDS conducts a critical assessment of CAPA submissions. The root cause analysis must be thorough and evidence-based, and corrective actions must directly address the systemic issue rather than treating symptoms. Superficial corrective actions—such as retraining alone without fixing underlying process deficiencies—are unlikely to be accepted, particularly for major nonconformities. For critical findings, MFDS may require additional verification or a follow-up inspection before closure is granted.