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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​

MFDS will assess whether root cause analysis is thorough and genuine. Superficial corrective actions (e.g., retraining only, without fixing the underlying process issue) are unlikely to be accepted for major nonconformities.