Prototype for evaluation — decision support only, not a substitute for quality-unit review. Uses pattern-based checks; a production version would layer an LLM + the full 483/warning-letter dataset underneath.

Prototype

The Corpus

Your 483 Response Reviewer

Paste your draft FDA Form 483 response and get a structured scorecard flagging what FDA reviewers are most likely to reject — before you send it.

Observation numbers being answered (optional — enables the coverage check) Draft 483 response

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⚠ Fix first — most likely to draw an FDA rejection