Data sources

FacilityLedger republishes U.S. FDA public data. Drug establishment registration comes from the FDA DECRS file; device registration and listing from openFDA; inspection classifications from the FDA Inspection Classification Database; warning letters from the FDA warning-letter database; and Form 483 observations from FDA-posted (redacted) versions.

How records are produced

The registry is rebuilt from source files, normalized by FEI number, stripped of personal contact fields, and checked for duplicate inspection dates and classifications. Search includes the complete imported registry. Public profile pages are a smaller evidence-rich subset with inspections, Form 483 observations, warning letters, or recalls.

Counts, compliance summaries, and profile text are generated deterministically from the cited fields. FacilityLedger does not use a language model to invent or pad facility records. A model-assisted summary may be introduced only when every statement is traceable to stored FDA evidence and the deterministic record remains available.

Form 483 coverage is incomplete. FDA posts only a subset of inspection observation reports, so a facility showing "None on file" may still have non-public observations. We show posted, FDA-redacted observations only, each linked to its source.

We exclude FDA food facility registration, which is statutorily non-public, and we omit personal contact names and emails from registration records.

Source: FDA public data · status as of 2026-08-22