Home / Who we serve / FDA inspection readiness
FDA inspection readiness
Be ready before FDA walks in.
Practical readiness support for consumer products manufacturers: the floor habits, procedures, investigations and purified water controls that investigators look at first.
Source: FDA recall and inspection data via Claraxis FDA Watch, 12 months to October 11, 2026. Drug-plant figures include OTC and prescription drug inspections.
The problem
Signs readiness needs attention.
Investigations land on operator error
Investigations stay open for weeks, or keep closing on “operator error” instead of the real cause.
Procedures and the floor disagree
The procedure says one thing and the floor does another, and nobody owns closing the gap.
Water trends are drifting
Purified water micro results trend up, or alert and action limits are hit more often than anyone admits.
How Claraxis helps
Readiness that lives on the floor.
- A floor-level walk-through the way an investigator would see it, findings ranked by risk
- Purified water system review: design, sanitization, sampling, trending, excursions
- Root cause and CAPA that close, checked for effectiveness
- Procedure and record clean-up with the people who run the work
- Front room and back room preparation for inspection day
- A 483 response plan inside FDA’s 15-business-day window
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.
- Led a USP purified water system modernization and built a 24/7 real-time operational dashboard.
- Process engineering and compliance (2016–19): equipment and utility validation, GMP and EHS.
- Plant manager of a global R&D pilot manufacturing center (2021–25), supporting 350+ scientists.
Roles held before founding Claraxis Group. Full background →
Questions
Answered.
Do you review USP purified water systems?
Yes. Water is often where contamination starts. Claraxis reviews purified water design, sampling, trending and excursion response, and offers a self-serve Water System Audit.
Can you help after we receive a Form 483?
Yes. Claraxis helps scope the root causes and corrective actions and structure a response within the 15 business days FDA expects, alongside your quality unit and counsel.
Is this regulatory consulting?
Claraxis provides operational readiness support. It is not a law firm and does not replace your quality unit’s responsibilities or regulatory counsel.
Start with the real challenge.
A 30-minute call, then a written scope before any commitment. Kobe replies personally within one business day.