FDA inspection database
RegDataLab holds FDA's inspection classifications for drug, device, food and biologics sites and links each inspection to its facility (FEI), its company and the citations it produced. Look up one supplier or count outcomes across an industry.
No key needed for the check. For the full record, connect RegDataLab or use the API.
What you can look up
Outcome of every inspection
NAI means no objectionable conditions were found. VAI means conditions were found but no action is recommended. OAI means regulatory and/or administrative actions are recommended.
Facility and company view
Each inspection is tied to an FEI, and each FEI to a company family, so a company search returns all of its sites.
Counts by year and outcome
Inspection statistics by fiscal year, product type and country, with the OAI share.
What followed
Recalls, warning letters and import alerts on the same facility, in one timeline.
Ask it in Claude or ChatGPT
- Show every FDA inspection of [company]'s facilities with the outcome and date.
- How many OAI drug inspections were there in India last fiscal year?
- Give me the compliance timeline for FEI [number].
50 credits now, 300 credits a month once you verify your email.
Questions
- What do NAI, VAI and OAI mean?
- NAI (No Action Indicated) means no objectionable conditions were found. VAI (Voluntary Action Indicated) means conditions were found but FDA is not prepared to take action. OAI (Official Action Indicated) means regulatory and/or administrative actions are recommended.
- Can I look up a facility by FEI number?
- Yes. Every facility page and the facility dossier tool take an FEI and return its inspections, citations, recalls and import history.
- Is the inspection database free?
- The record pages and the company check on this page are free with no key. 50 credits now, 300 credits a month once you verify your email.
- How do I use RegDataLab in Claude or ChatGPT?
- Add https://www.regdatalab.com/mcp as a custom connector (Claude: Customize, Connectors, Add custom connector; ChatGPT: add a custom MCP server with OAuth), sign in with your key, then ask in plain English. 50 credits now, 300 credits a month once you verify your email.
- Is RegDataLab part of the FDA?
- No. RegDataLab is an independent data product built on public FDA records. It is not affiliated with, endorsed by, or sponsored by the U.S. Food and Drug Administration.
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