[GMP Update] On-Site Verification of Corrective Actions (February 2024).

MFDS advised that where issues affecting quality management require an on-site follow-up—such as missing procedures or infrastructure qualification—the review body should discuss the situation with the company, stop the audit and agree on a follow-up visit. The applicable audit withdrawal fee is charged under the operating rules.

Supporting documents should be reviewed thoroughly before the visit. If concerns emerge during document review, discuss them with the company early to avoid an unnecessary audit withdrawal.

Decisions should be made carefully to avoid delays. If an audit is withdrawn, the site's responsible person should receive a clear explanation following discussion.

For periodic audits, the issue may constitute non-compliance with Article 27(1)(11) or Article 33(1)(15) of the Enforcement Rule of the Medical Devices Act and should be reported to the competent regional MFDS office.

Contact BCG for further information.

https://emedi.mfds.go.kr/gmp/aply/view/MNU20284?&pstSno=7&bbsSno=1340