FDA Intel

FDA Intel brings FDA inspection intelligence into Claude. Research FDA-inspected drug, biologics, device and food sites, FDA investigators and 21 CFR sections, with underlying documents linked.

What you can ask:

• A site's FDA standing by name or FEI: inspections and outcomes (NAI/VAI/OAI), warning letters and close-out status, import alerts, recalls, import refusals and registrations.
• Inspection history with FDA-published 21 CFR citations.
• Form 483s, establishment inspection reports, warning letters and responses: search by firm, FEI, investigator, date, location, regulation or observation wording; read summaries and observation previews with document links.
• Investigator profiles: frequently cited regulations, inspection length, OAI share, sites and co-investigators.
• 21 CFR sections and citation patterns.
• FDA public records: recalls, drug shortages, registrations, 510(k), PMA, NDC, Drugs@FDA applications and debarment.

Typical uses include pre-inspection briefs, supplier and CDMO qualification, 483 response research, competitive intelligence and investment diligence.

All 27 tools are read-only. An FDA Intel account is required. Standard is $89/month for 1 user and 10,000 requests/month; Premium is $249/month for up to 3 users and 50,000 requests/month.