Who it's for
Built for the people who answer to FDA.
Quality, regulatory, supplier and diligence teams use the same record: what FDA investigators wrote, at which site, and what happened next.
Find your team
Each page shows how teams like yours use Form 483s, EIRs and warning letters, with real examples.
Inspection readiness
A step-by-step guide from inspection notice to Day 1, with what FDA cites most.
Read more →Supplier quality
Check a supplier's FDA record before you sign: 483s, warning letters and close-outs.
Read more →Pharma quality and regulatory teams
Prepare for drug GMP inspections with the Form 483s FDA wrote at sites like yours.
Read more →Biotech and biologics teams
Get ready for a first pre-approval inspection and check your CDMO before you depend on it.
Read more →Medical device quality teams
See how FDA writes up CAPA, complaint handling and design controls at device makers.
Read more →Contract manufacturers (CDMOs and CMOs)
Qualify CDMO sites on their FDA record, and show your own clients you are ready.
Read more →Inspection and compliance consultants
Build mock inspections and 483 responses on FDA's real wording for every client.
Read more →Investors and analysts
Read the inspection record behind a company's sites before a decision date.
Read more →Law firms
Find the Form 483, warning letter or response a matter turns on, fast.
Read more →
How a team uses it
Search
Look up a firm, FEI number, FDA investigator or the wording of an observation.
Check the facts
Each document page shows the site, dates, investigators and regulations cited.
Download the original
Pay per document. Downloads start as soon as checkout finishes.
Questions
Who uses FDA Intel?
Quality and regulatory teams at drug, biologics and device makers, supplier quality and CDMO teams, inspection consultants, investors and law firms.
What documents can I find?
Form 483s, establishment inspection reports (EIRs), 483 and warning letter responses, warning letters and close-out letters.
Do I need a subscription?
No. Documents are bought one by one, with no subscription. The AI connector for Claude and ChatGPT is a subscription, from $78/month, billed yearly or billed monthly. Custom reports are priced per project.