The Finding
24 warning letters. Every one followed a CAPA that was already closed.
Source-verified, single-analyst coding across FDA warning and untitled letters issued to 503B-registered facilities, January 2024 through June 2026. 100% had implementation evidence. 75% had no proof the root cause was real. Half never assessed related exposure.
Read the full source-verified research report (PDF) →Preview — Leadership Assessment Sheet
| Control Dimension | Rating (1–4) | Leadership Note |
|---|---|---|
| Root-cause adequacy | Not rated | Would an independent reviewer understand why the cause is supported? |
| Implementation evidence | Not rated | Can leadership retrieve approved changes and completion artifacts? |
| Effectiveness / recurrence | Not rated | Are pass/fail criteria and recurrence trends visible to management? |
What You Leave With
Not a report to read. A decision to make, with Quality and Regulatory, in one sitting.
It identifies latent liability in closed CAPAs, documents the authorization behind each call, and gives investigators objective evidence of control — not just closure dates.
01
Know where you're exposed
Executive Brief
The leadership decision, the cohort risk translated into plain terms, and priority actions with named owners.
02
See the full evidence
Executive Findings
Record-level detail behind the cohort — facility, letter type, and failure rate by control dimension.
03
Score your own system
Leadership Assessment
A 1–4 rating of your own CAPA system, against the same five dimensions — evidence available, not intended practice.
04
Leave with a plan, not a diagnosis
90-Day Action Plan
Named decisions, executive and operational owners, due dates, and required evidence of completion.
$295 per facility. Applied as full credit toward the $497 IRR if purchased within 30 days.
Get the Executive Review → Who This Is For
Built for the people who authorize the decision — not a training audience.
—QA Directors and VP Quality who run CAPA closure through management review and can't yet prove closure means control.
—Regulatory Affairs leadership whose last inspection cited — or could cite — a closed CAPA with no effectiveness evidence.
—Site and manufacturing quality heads who need a scored answer for leadership, not another closure dashboard.