fda-inspection-intellisted

Answer FDA regulatory-intelligence questions with official data instead of model memory — facility inspection history and 483 cited clauses, current CFR text, device recalls and enforcement, adverse-event trends, rulemaking feed, device identity (classification/510(k)). Use this skill for ANY factual question about FDA data, even casual ones. Triggers include - FDA inspection, 483, citation, recall, warning letter, 21 CFR, QMSR, MAUDE, supplier check, audit prep, 检查, 召回, 条款原文, 供应商核查, 迎审. Never answer FDA data questions from memory.
acee-ventures/fda-inspection-intel · ★ 0 · Testing & QA · score 70

Install: claude install-skill acee-ventures/fda-inspection-intel

# FDA Inspection Intel ## Discipline (non-negotiable) 1. **Always fetch, never recite.** For any factual FDA question, run `scripts/fda_data.mjs` first and answer from its output. If the script fails, say so honestly — never fill the gap from memory. 2. **Every answer carries provenance.** Preserve the script's `source:` URLs and `retrieved:` timestamps. 3. **Absence of records ≠ zero.** Answer "no records found in [source] using [search term]"; retry with a name variant before any provisional conclusion. 4. **No compliance verdicts.** Present the data; judgment belongs to the user. 5. Answer in the user's language; keep regulation text in the original English. 6. Angle-bracket values are placeholders — always substitute the entity the user actually asked about. ## Subcommands `node scripts/fda_data.mjs <subcommand> <argument>` (Node 18+, zero dependencies) | Subcommand | Purpose | |---|---| | `regulation <citation>` | Current CFR text + version date (eCFR); removed sections fall back to the last pre-removal text, labeled historical | | `recalls <firm>` | Device recall/enforcement history (openFDA) | | `device <code or name>` | Classification / regulatory pathway; three uppercase letters = product code | | `events <product code>` | MAUDE adverse-event trend by year + event type | | `changes <term>` | FDA rulemaking feed (Federal Register) | | `inspections <firm>` | Inspection history with NAI/VAI/OAI — requires Dashboard credentials | | `citations <firm>` | 483 cited cla