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cGMP Readiness Assessment · your first step
Know where you stand before FDA does.
A fixed-scope review of your site against current good manufacturing practice, on-site or remote. You get written findings ranked by inspection risk and a prioritized plan your team can act on. For OTC, cosmetics and personal care manufacturers in the US and EU.
Who this is for
Leaders who want an outside read.
Plant and operations leaders
You run an OTC, cosmetics or personal care site and want an independent view before an inspection or a customer audit.
Heads of quality
You need a ranked list of gaps and a plan you can defend to leadership and to auditors.
Owners of growing manufacturers
You have added products, lines or customers and are not sure your systems kept up.
What the engagement includes
Findings and a plan you can act on.
- A scoping call: products, site, recent inspection and audit history, and what matters most to you
- Document and record review: procedures, batch records, deviations and investigations, CAPA, complaints, training and change control
- A walk of the floor, on-site or by live video: production, warehouse, laboratory and utilities, including purified water
- Conversations with the people who run each system, asked the way an investigator would ask
- Written findings, each tied to the requirement it relates to and ranked by inspection risk
- A prioritized plan: what to fix first, who owns it, and what evidence will show it is done
- A readout with your leadership team
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.
Can it be done remotely?
Yes. On-site adds a direct walk of the floor; remote uses document review and a live video walk-through. Both follow the same scope and end with the same written findings and plan.
What does it cost and how long does it take?
A fixed fee of [PRICE], agreed in writing before any work starts. Typical duration: [DURATION].
What do you need from us?
Access to your procedures and records, time with the people who run the key systems, and a confidentiality agreement. An NDA is signed before any data is shared.
What happens after the assessment?
Your team can run the plan on its own. If you want help carrying it out, that is scoped separately, in writing, before any commitment.
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.