MFDS Audit Notices Arrive With 30 to 60 Days' Notice. Your Compliance Gaps Take Longer Than That to Fix.
Audit preparation that begins after notice arrives is remediation under time pressure — gaps that could have been prevented become inspection findings. MFDS inspectors examine both QMS compliance and technical file accuracy simultaneously.
A Structured Audit Readiness Program Covering Both QMS and Technical File Dimensions — Before the Inspector Arrives.
We conduct parallel reviews of QMS compliance and technical file status, identify gaps, prioritize remediation by inspection risk, and prepare your team for the inspection itself.
KGMP QMS Gap Analysis + Technical File Gap Analysis
Running simultaneous gap reviews — QMS records against KGMP inspection criteria and technical files against current MFDS STED requirements — to map the full scope of gaps before any remediation begins.
Vigilance / Adverse Event Reporting + Change Notification Management (Records Review)
Reviewing your adverse event reporting record and change notification history for completeness and compliance — the two post-market record areas MFDS inspectors consistently examine and where gaps are most commonly found.
Training & Competency
Delivering inspection-specific training to personnel who will interact with MFDS inspectors — covering document retrieval, record presentation, inspector query protocols, and how to handle requests for evidence they have not encountered before.
Every Gap You Find in Preparation Is One the MFDS Inspector Does Not Find in the Inspection Room.
Prioritized by Inspection Risk, Not by Perfection
We prioritize remediation by what MFDS inspectors are most likely to examine and flag — so that your preparation time is concentrated on the highest-risk gaps, not distributed evenly across a full QMS review.
On-Site Inspection Support Available
We provide on-site support during the actual MFDS inspection — document coordination, real-time liaison, and post-day debriefs — reducing the operational stress of the inspection day and preventing avoidable information gaps during inspector queries.
MFDS Inspections Passed for Manufacturers Across Multiple Device Categories.
45-Day Audit Preparation for a Manufacturer With Multiple Compliance Gaps
Conducted dual-scope QMS and technical file gap review for a North American manufacturer with an MFDS inspection in 45 days — identified and prioritized 23 gaps, executed remediation on all high-risk items, and supported the inspection day, resulting in zero major non-conformances.
Pre-Scheduled Surveillance Inspection Readiness for a European Portfolio
Completed a proactive audit readiness review for a European manufacturer before a scheduled MFDS surveillance inspection — confirming full compliance for three product lines and identifying and closing two latent change notification gaps before the inspector arrived.
An Audit Readiness Report and a Remediation-Prioritized Preparation Plan.
A gap identified in our review is a gap you can close before it becomes a finding. Leanabl conducts audit readiness reviews using the same criteria MFDS inspectors apply.
Speak with an Audit Readiness Specialist TodayFrequently Asked Questions
Common questions answered.