FDA compliance records
Quality · supplier quality
Review a supplier's public inspections, warning letters, recalls and import alerts. Check the company and site match before using the evidence in a supplier review.
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Review public FDA records by supplier and site. The supplier watchlist pilot will put changes and source evidence in a daily digest, so you can decide what needs follow-up.
Try , , . Free, no signup.
Pilot applications open. $199 USD a month for up to 25 suppliers. Starts after readiness checks.
Inspection classification revised.
Fictional supplier and record. Review the full sample for matching and source freshness.
Quality · supplier quality
Review a supplier's public inspections, warning letters, recalls and import alerts. Check the company and site match before using the evidence in a supplier review.
Supplier watchlist pilot
The proposed watchlist keeps confirmed suppliers under observation. A daily digest will show changed records, source links and any failed checks. Applications are open for five pilot slots.
Developers · researchers
The existing REST API and MCP tools return company and facility records for your own lookups. API access is a separate offer from the watchlist pilot.
Confirm aliases, subsidiaries and facility FEIs before widening a search. Unresolved names and failed checks need review. No matching records does not establish safety.
| Record | FDA source | Coverage limit |
|---|---|---|
| Inspections and citations | FDA Data Dashboard | NAI (no action indicated), VAI (voluntary action indicated) and OAI (official action indicated). Citations are not every Form 483. |
| Form 483 and inspection documents | FDA OII FOIA Electronic Reading Room | Published documents only. The public collection is incomplete. |
| Warning letters | FDA warning-letter index | Issue dates and posting dates can differ. Later responses may change the record. |
| Recalls | openFDA enforcement and FDA iRES | Reported recalls and status changes. Facility matching depends on available identifiers. |
| Import alerts | FDA Import Alerts | Firm listings require a confirmed company or site match. |
| Company debarments | FDA debarment lists | Corporate entries only for the proposed watchlist. |
RegDataLab uses public data and is independent of the FDA. Publication delays and incomplete records affect coverage.
Use REST or MCP to look up companies, facilities and FDA compliance records. API plans use credits per successful tool call. They do not include the watchlist pilot.
Claude Code, with a free API key:
claude mcp add regdatalab https://www.regdatalab.com/mcp \
--transport http \
--header "Authorization: Bearer YOUR_API_KEY" \
--scope userDemo API key
fda_demo_GKNDjUOjPbhLZZVPvRHDlY3zP_H3HXzTMRbHVD_I5rgThe public demo key allows up to 50 credits of calls per IP address.
Example query
fda_manufacturing_risk_summary company="Pfizer"Use the source links in the response to check the company and site match.
Five pilot slots for quality and supplier-quality leads. We will confirm supplier matches, coverage and readiness before a paid start.
Review a sample digest