Findings are tiered by the strength of their support.
Direct precedent match
The claim or presentation closely mirrors language or structure FDA has specifically cited before.
Analogous precedent
A related enforcement action or guidance passage bears on the issue, without being a direct match.
Regulatory principle, no direct precedent
The concern is grounded in a statute, regulation, or guidance principle, even where no specific enforcement example exists.
Why this matters
This tiering lets your team triage: address direct-precedent findings with urgency, and treat principle-based findings as informed judgment calls rather than false alarms.
It also means every output is defensible — internally, to a committee, or in an audit — because the reasoning chain is visible rather than asserted, and grounded in a framework shaped by someone who made these calls at FDA.
Every assessment retains its full citation trail.
Supporting internal documentation of a systematic, good-faith promotional review process.
See a sample citation trail.
Walk through a real finding, its evidence tier, and its full source trail.