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Mock FDA inspection
Rehearse the inspection before FDA arrives.
A mock inspection run the way an investigator works: the walk-through, the document requests and the questions. Your team practices under realistic pressure, and you get written findings to fix before the real visit.
Who this is for
Sites with an inspection on the horizon.
An inspection is due
A routine or follow-up FDA visit is expected and you want no surprises.
A new team in the room
Front-room hosts and subject-matter experts who have not yet faced an FDA investigator.
After a Form 483
You have closed observations and want to test that the fixes hold up under questioning.
What the engagement includes
The real thing, without the consequences.
- Planning: the systems to cover and how your site normally hosts an inspection
- Front room and back room set up the way you would run them on the day
- A facility walk-through with the questions an investigator is likely to ask
- Timed document requests: batch records, deviations and investigations, CAPA, complaints, training and cleaning records
- Interviews with your subject-matter experts, with coaching on clear, factual answers
- A daily debrief and a written report of findings ranked by risk
- A short plan for closing the gaps before the real inspection
Who you work with
Kobe Ofori-atta, founder.
“What set Kobe apart was technical rigor combined with sound judgment. He was the FDA point of contact for the pilot plant in Piscataway. He doesn’t stop at diagnosing a problem; he builds the system that keeps it fixed.”
Relevant experience
- Primary site FDA contact; hosted FDA inspections and quality audits, with zero major findings.
- Process engineering and compliance (2016–19): equipment and utility validation, GMP and EHS.
- Led a USP purified water system modernization and built a 24/7 real-time operational dashboard.
- Plant manager of a global R&D pilot manufacturing center (2021–25), supporting 350+ scientists.
Roles held at Colgate-Palmolive before founding Claraxis Group. Full background →
Questions
Answered.
Is this an FDA inspection or a certification?
No. It is an independent review to help you prepare. It is not an FDA inspection, an audit certificate or a guarantee of any inspection outcome.
How long does it take?
Typically [DURATION], depending on how many systems are in scope. The scope and schedule are agreed in writing first.
Can it be run remotely?
Partly. Document requests and interviews work well by video. The facility walk-through is best done on-site.
Will the findings be shared with FDA?
No. The report is yours, under a confidentiality agreement signed before any data is shared.
What does it cost?
A fixed fee of [PRICE] for the agreed scope.
Is this legal or regulatory advice?
No. Claraxis provides operational and quality systems support alongside your quality unit. Bring in regulatory counsel where legal judgment is needed, especially if a warning letter is likely.
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Start with the real challenge.
A 30-minute call, then a written scope before any commitment. Kobe replies personally within one business day.