Non-Conformity Findings in Medical Device KGMP Audits.

A KGMP audit may result in a non-conformity decision where a violation of Korea's Medical Devices Act is identified.

Common examples include:

※ Refusing an audit without justification or preventing it from proceeding

→ The site refuses access or is closed on the agreed audit date.
→ Inadequate interpreting or withdrawal prevents the audit from proceeding.

※ Failing to establish QMS documentation

→ Most procedures and methods required by Annex 2, section 2(b), of the Enforcement Rule of the Medical Devices Act are not documented.

※ Failing to follow the documented QMS procedures

→ A one-year calibration interval is specified, but some instruments remain uncalibrated and no proactive corrective action is taken.

※ Falsified records or documents, including data manipulation

Contact BCG if you need support developing corrective actions for KGMP audit non-conformities.