FDA compliance intelligence
Know which citation patterns become warning letters — before they do.
FDA publishes everything: 483 observations, recalls, adverse events, warning letters. It's free, messy, and unread. We pipe it, structure it, and attach expert verdicts — so quality managers at device companies see escalation risk without paying a consultant $300/hour to read PDFs.
3,500+
warning letters on fda.gov — unstructured HTML nobody monitors systematically.
~50k
device adverse-event reports flow into MAUDE every year for a single busy product category.
$300+/hr
what consultants charge to interpret it — per engagement, with no memory between clients.
How it works
1 · Pipeline
Automated ingestion of recalls, MAUDE, warning letters, and inspection citations for your product codes — refreshed weekly, normalized into one schema.
2 · Verdicts
An analyst who understands the regulatory logic labels each signal: severity, root-cause category, and whether the pattern predicts escalation. Every engagement adds labeled records.
3 · Radar
The verdict history makes the radar smarter: scoring stops being a heuristic and starts being fit to observed 483 → warning-letter escalations. That data asset compounds and doesn't copy.
Warning Letters
Live feed from fda.gov — issue date, issuing center, and violation subject for every letter, current to this week.
Device Recalls
Every recall event with FDA's own root-cause determination — design, software, process, supplier.
MAUDE Adverse Events
Millions of device adverse-event reports, trended by product category to catch acceleration early.
Form 483 Observations
Inspection citations by CFR clause via FDA's Data Dashboard — the leading indicator everything else lags.
Pricing
Exposure Assessment
$5kone-time
A senior-analyst read of your product category and firm: citation history, recall patterns among competitors, the specific observation patterns that have escalated to warning letters, and where your quality system is exposed.
2-week turnaround
Monitoring Subscription
$500–2k/month
The pipeline watches your product codes, competitors, and suppliers weekly. You get alerts with an expert verdict attached — not a data dump: what changed, whether it matters, what to do.
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Verdict Data & API
2027waitlist
Expert-labeled escalation verdicts as eval sets, benchmarks, and training data for regulatory AI — plus MCP/API access to the live risk pipeline.
Join the waitlist
Want an exposure assessment for your product category?