12 hours,
with severity.
FDA Form 483 observations and Warning Letters, parsed within 12 hours of publication, with per-inspector severity scoring and repeat-finding flags. Built on the openFDA + FOIA pipeline, delivered to your inbox, Slack, or API.
Built on public sources. Informational, not compliance or legal advice.
New 483s and Warning Letters are read and structured within 12 hours of publication.
Per-inspector severity scores and flags for repeat findings across sites.
Delivered by newsletter, Slack, or API — fitted to how your QA team already works.
How it works
- 01We watch the public record.openFDA plus FOIA-sourced 483s and Warning Letters, monitored continuously.
- 02We parse and score.Each document is structured, scored for severity by inspector, and checked for repeat findings.
- 03You get the signal.Within 12 hours, in your inbox, Slack, or via API — with the context your QA team needs.
Pricing
A free weekly newsletter of the week's notable 483s and Warning Letters, with trends.
12-hour alerts with severity and repeat-finding flags, filtered to your sites, products, and inspectors. Pricing shared on request.
FAQ
Publicly available FDA records via openFDA and FOIA. We structure and score them; we don't have non-public access.
No. 483 Signal is informational. It helps your team see and prioritize what's published; it doesn't tell you what to do about your own compliance — that's your QA and counsel.
It's our analytical estimate based on the document text and history. We're transparent about how it's derived; underlying government data can change or be corrected.
Yes, on the pro feed — filtered by site, product, supplier, or inspector.
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The week's notable 483s and Warning Letters, with trends. Unsubscribe anytime.