Few phrases make quality teams more anxious than “unannounced audit.”
Whether it’s a Notified Body conducting a surprise visit under the EU MDR/IVDR or an FDA investigator arriving unannounced for an inspection, these audits test your organization’s true level of compliance readiness.
The key to success? Treat every day as audit day.
1. What Is an Unannounced Audit?
EU Notified Bodies
Under the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746), Notified Bodies are required to conduct unannounced audits at least once every three years.
These visits verify that:
• Manufacturing and quality processes match the approved technical documentation.
• Products on the line correspond to the CE-marked version.
• The quality management system (QMS) is operating effectively.
Auditors may even sample products, review batch records, and perform on-the-spot verifications.
FDA Inspections
The U.S. Food and Drug Administration (FDA) conducts for cause, surveillance, or pre approval inspections and most are unannounced.
FDA inspectors (from CDRH, CBER, or CDER) may arrive without prior notice, especially for:
• Routine GMP or QSR compliance inspections.
• Follow-ups to previous 483s or warning letters.
• Complaint investigations or adverse event triggers.
2. What Auditors Will Look For
Regardless of region, inspectors will assess:
• Quality Management System (QMS) effectiveness (ISO 13485 / 21 CFR 820 / QMSR).
• Batch records and traceability from raw material to release.
• Complaint handling, CAPA, and nonconformance management.
• Training and competency of personnel.
• Document control and version history.
• Supplier qualification and monitoring.
• Data integrity — ALCOA+ principles applied to electronic and paper records.
• Change control and post-market surveillance records.
If you’re not maintaining these routinely, you’re not ready for an unannounced audit.
3. Steps to Prepare for an Unannounced Audit
1. Maintain “Always Ready” Documentation
• Keep controlled copies of all current SOPs accessible to staff.
• Ensure batch records, calibration logs, and validation reports are completed, signed, and filed immediately after activities.
• Store documentation in a centralized system (ideally an eQMS) with audit-ready access.
2. Define an Audit Response Procedure
Every organization should have a formal Audit/Inspection SOP that defines:
• Who greets inspectors and verifies credentials.
• Who serves as the main point of contact (“audit host”).
• How documents are requested, reviewed, and copied.
• Where auditors are seated (designated conference or audit room).
• How to handle staff interviews and facility tours.
Training all employees on this SOP ensures calm, consistent responses.
3. Conduct Regular Internal and Mock Audits
Simulate unannounced audits at least once a year.
• Rotate internal auditors to ensure objectivity.
• Perform mock FDA or Notified Body audits with external experts to identify weaknesses.
• Review findings during management review and track CAPAs to completion.
4. Keep Personnel Prepared and Confident
Auditors often ask operators direct questions. Everyone should know how to respond:
• Be truthful, concise, and confident.
• Only answer what’s asked, do not speculate.
• If unsure, refer the auditor to the appropriate person or document.
• Avoid discussing other unrelated areas.
Conduct periodic “audit readiness refreshers” for all staff.
5. Ensure Your Facility Reflects Compliance
Inspectors observe paperwork and your environment.
• Keep production areas clean, organized, and labeled.
• Verify calibration stickers, equipment logbooks, and maintenance schedules.
• Confirm that materials are segregated (quarantined, approved, rejected).
• Check access control and labeling compliance.
6. Strengthen Supplier Oversight
Notified Bodies can audit critical suppliers without notice.
• Keep supplier qualification files, questionnaires, and agreements current.
• Ensure your suppliers understand your regulatory expectations.
• Audit key vendors periodically and review their CAPA responses.
7. Verify Training and Competency Records
Auditors routinely review training documentation.
• Ensure each employee has a current training matrix.
• Confirm completion of training on new or revised SOPs.
• Link training records to corresponding document versions.
8. Address Past Findings Proactively
If your organization has received 483s, nonconformances, or audit findings:
• Verify CAPA effectiveness.
• Keep evidence of corrective actions readily available.
• Be prepared to discuss lessons learned and continuous improvement.
4. During the Audit
When auditors arrive:
• Greet them professionally and confirm credentials.
• Notify key personnel and implement your Audit SOP immediately.
• Escort them to the designated area; maintain professionalism at all times.
• Provide requested documents promptly and accurately.
• Take detailed notes during all sessions, especially on observations or concerns.
• Conduct daily debriefs to track potential findings and prepare responses.
5. After the Audit
• Review preliminary findings during the closing meeting.
• Acknowledge all feedback professionally
• Document all observations and begin drafting responses immediately.
• Assign CAPAs with root cause analysis and due dates.
• Update management review with outcomes and lessons learned.
If you receive an FDA Form 483 or Notified Body nonconformance report, respond within the required timeline (typically 15 days for FDA) with clear corrective actions and supporting evidence.
6. Common Pitfalls to Avoid
• Waiting for an audit announcement to organize documentation.
• Inconsistent version control between departments.
• Untrained employees giving incorrect or incomplete answers.
• Outdated calibration or maintenance records.
• Delayed CAPA closures or missing effectiveness checks.
How Avendium Can Help
At Avendium, we help life science and diagnostic manufacturers achieve and maintain inspection readiness for FDA, Notified Body, and ISO audits.
Our experts provide:
• Mock unannounced audits aligned with FDA and MDR/IVDR expectations.
• Audit/Inspection SOP development and training.
• CAPA and root-cause analysis support.
• eQMS implementation for documentation control and audit tracking.
• Ongoing QA oversight and audit preparedness programs.
With Avendium, you can move from reactive compliance to proactive confidence, ready for any audit, any day.
Contact us today to strengthen your audit readiness program.