The FDA Inspection Database — formally the FDA Inspection Classification Database — is a free, public search tool at accessdata.fda.gov/scripts/inspsearch that lists the outcome classification of closed FDA inspections by facility. A companion resource, the FDA Inspections Data Dashboard, presents the same underlying dataset in a browsable, filterable dashboard format.
Neither tool hosts the actual inspection report or Form FDA-483 itself — they publish only the classification outcome and a small set of identifying fields.
What the database actually contains
For each closed, classified inspection, the Inspection Classification Database returns:
- Firm/facility name and location (city, state, country)
- Inspection end date
- FDA project area (e.g., drug quality, bioresearch monitoring/clinical investigator, device, biologics)
- The final classification assigned to that project area: NAI, VAI, or OAI (defined below)
It does not include the narrative content of the inspection — the specific observations, the investigator’s findings, or the underlying Form FDA-483 itself. Those documents are separately obtainable, generally through a Freedom of Information Act (FOIA) request to FDA (redacted 483s and Establishment Inspection Reports, or EIRs, are routinely released this way once an inspection is closed). Some FDA offices also post redacted 483s directly for specific inspection categories, but that coverage is inconsistent across centers — FOIA remains the reliable path for a specific facility’s full inspection record.
The three inspection classifications
Every closed, classified inspection resolves to one of three outcomes, applied per project area rather than to the firm as a whole:
- NAI — No Action Indicated: the facility was found in an acceptable state of compliance. Typically no Form FDA-483 was issued.
- VAI — Voluntary Action Indicated: objectionable conditions were observed, but FDA determined the firm can correct them voluntarily and does not plan to recommend regulatory or administrative action. A Form FDA-483 was typically issued at the close of the inspection.
- OAI — Official Action Indicated: the facility is in a state of noncompliance serious enough that FDA may pursue further regulatory action — a warning letter, an import alert, seizure, injunction, or a clinical hold, depending on the facility type and findings.
A single sponsor or site can carry different classifications across different project areas or across different inspections over time; the database records each inspection’s classification separately rather than producing one lifetime score for a facility.
What’s excluded from the public database
FDA’s own guidance on the tool lists several categories of inspection that are never included, regardless of how much time has passed:
- Inspections conducted by state agencies under contract to FDA
- Pre-approval inspections (PAIs)
- Mammography facility inspections (covered under a separate MQSA program)
- Inspections still awaiting a final enforcement action or classification decision
- Inspections of nonclinical (GLP) laboratories
Because the dataset is refreshed on a weekly cadence and only includes inspections that have already reached final classification, a very recent inspection at a given site may not yet appear — absence from the database is not evidence an inspection didn’t happen, only that it hasn’t been publicly classified yet.
How this fits into FDA’s Bioresearch Monitoring (BIMO) program
For clinical trial sponsors and institutions specifically, the inspections most relevant in this database sit under FDA’s Bioresearch Monitoring (BIMO) program — the arm of FDA’s inspection activity that covers clinical investigators, sponsors, institutional review boards (IRBs), and nonclinical laboratories, verifying that trial conduct and data match what was submitted to the agency and that human-subject protections were followed. A BIMO inspection classification, filtered to a specific investigator or sponsor’s project area, is one of the more direct signals in the public record of how a given site or sponsor has performed under FDA scrutiny.
Practical uses for research administrators
- Site and CRO due diligence: before activating a new investigator site or contracting a CRO, checking that facility’s inspection history for OAI classifications or a pattern of VAI findings is a standard part of sponsor oversight and vendor qualification.
- Monitoring your own institution’s record: research administration and quality offices commonly track their own site’s classification history as part of inspection readiness preparation and to spot recurring finding categories before the next inspection.
- Benchmarking and risk assessment: sponsors building risk-based monitoring plans (consistent with ICH E6 GCP‘s risk-based oversight expectations) use classification history across a portfolio of sites as one input into where to concentrate monitoring resources.
- Distinguishing this from Warning Letters: an OAI classification does not automatically mean a warning letter was issued — FDA’s separate Warning Letters database tracks the subset of enforcement correspondence FDA actually sent, and the two datasets should be checked separately rather than assumed to move together.
How the search tool works, and its limits
The Inspection Classification Database search accepts a firm name (with wildcard/partial matching), city, state, country, FEI (Firm Establishment Identifier) number, or a date range, and returns matching classified inspections. Two limitations matter for anyone using it for due diligence rather than casual lookup: firm names in FDA’s records are not always standardized (a facility that has changed names, been acquired, or is listed under a parent-company variant may require several search attempts), and because the dataset is project-area-specific rather than firm-wide, a facility can show an NAI classification for one project area and a VAI or OAI for another from the same broader inspection visit. Reading only the top-level result without checking which project area a classification applies to risks over- or under-stating a site’s actual compliance history.
Frequently asked questions
Is the FDA Inspection Classification Database the same as the FDA Data Dashboard?
They draw on the same underlying dataset, but present it differently. The Inspection Classification Database (accessdata.fda.gov/scripts/inspsearch) is a direct search form for individual classified inspections. The FDA Data Dashboard (datadashboard.fda.gov) offers a broader, filterable interface across several FDA compliance datasets, including inspections, and is generally easier for exploring trends across many facilities rather than looking up one specific firm.
Can I get the actual Form 483 or inspection report from the database?
No. The public database returns only the classification outcome and identifying details, not the narrative findings. The Form FDA-483 and the full Establishment Inspection Report (EIR) are obtained separately, typically via a FOIA request to FDA once the inspection is closed and any associated enforcement matter resolved.
How current is the data?
FDA states the dataset is updated on a weekly basis, and only reflects inspections that have already reached a final classification — inspections still pending a classification decision are not shown yet.
Does a VAI classification mean my site failed the inspection?
Not in the sense of triggering enforcement action. VAI means FDA observed objectionable conditions but determined the firm could correct them voluntarily, with no regulatory action recommended. It is still a documented finding that sponsors and quality offices typically track and remediate, but it is a materially different outcome from OAI, which signals FDA may pursue further regulatory or administrative action.
For the broader compliance framework this inspection activity sits within, see CASRAI’s clinical research administration overview, and for the documentation produced during an inspection itself, see Form FDA-483.
