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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 the root cause analysis is thorough and whether corrective actions address the systemic issue. Superficial corrective actions such as retraining alone, without fixing the underlying process deficiency, are unlikely to be accepted, particularly for major nonconformities.