The Full Dress Rehearsal
Mock
Inspections
Run by Former Investigators
at Real-Inspection Intensity
Run by Former Investigators
at Real-Inspection Intensity
Every site believes it is ready until someone starts asking questions with a badge on the table. A mock inspection is the only way to find out what is actually true — how fast documents really surface, what your SMEs really say under pressure, where the story really breaks. Ours are run by former FDA investigators and notified-body auditors who conduct the exercise exactly the way they conducted the real thing, because they did.
An SME who over-answers in rehearsal will over-answer for real. Better to learn it now.
A rehearsal only works if the pressure is real. So we replicate the experience precisely — and then use the one difference that matters: this time, the findings belong to you alone.
We run it on you first, at the depth and scope FDA would, before FDA ever arrives.
Intensity should match where you are: a site six months from a PAI needs a different exercise than one hardening an established program. Every format ends with a written report and a debrief.
A concentrated audit of one or two quality systems — CAPA, batch records, training, data integrity — with live document pulls against the clock and a same-week findings memo.
A full-site inspection compressed: opening meeting, facility walk, interviews with key SMEs, and a closing meeting with preliminary observations delivered investigator-style.
The complete rehearsal: unannounced arrival, multi-investigator team, front-room/back-room operations under load, nightly debriefs, and a formal mock-483 with a closing meeting.
Paper audits find paper problems. A live simulation finds the behavioral ones — the failure modes that never show up in a desk review because they only exist under pressure.
The brilliant SME who answers the question asked, then the question not asked, then volunteers the one thing you spent a year remediating.
The record that exists, is compliant, and takes ninety minutes to find — which reads exactly like a record that does not exist.
Two truthful SMEs describing the same process two different ways, handing the investigator a thread to pull for the rest of the week.
The question nobody owns — so someone guesses, and the guess becomes a statement the site now has to live with.
One dispatcher, four simultaneous requests, no triage rule — and the front room starts feeling the silence.
A known weakness with a rehearsed one-liner that collapses at the second follow-up question. Storyboards have to survive round three.
The facility walk goes where the investigator wants — the rehearsal has to wander the same way.
The exercise ends the way an inspection ends: a closing meeting and a written report — except this one comes with severity grading, root-cause hypotheses, and a remediation sequence.
The real value is in the annexes — the parts no agency report will ever contain:
You leave with a ranked findings list, a remediation path, and a re-test plan that proves the fixes took.
A mock inspection is only as honest as the person running it. Ours are led by former FDA investigators and industry quality heads who have issued and answered real 483s — people who know the difference between inspection theater and inspection truth.
Led by people who conducted the real inspections — PAIs, surveillance, for-cause — across drugs, biologics, and devices.
Findings graded as an agency would grade them, so you remediate in the order the risk actually runs.
Every exercise doubles as training: your team ends the week measurably better at being inspected.
Results stay privileged and private. The whole point is finding it here first.
A mock inspection is one instrument in a readiness program. These are the services sites pair with it most.
The standing posture the rehearsal tests — rooms, roles, retrieval, and the discipline that holds between drills.
Explore Readiness →The mock-483’s findings, closed through corrective action that would satisfy the real inspection.
Explore CAPA →The audit programs and quality systems the rehearsal examines, built and maintained by the same team.
Explore GxP →Tell us about your site, your product, and the inspection on your horizon. We’ll scope the right exercise and match you with a former-investigator lead, with a response within one business day. All inquiries are strictly confidential.
