Use case: investor diligence
Read the inspection record before the decision date.
For a drug site with serious inspection findings, FDA can hold back approval of applications that name it. The record of the manufacturing sites can matter as much as the data.
The short answer
Identify the manufacturing sites, open each one by FEI number, and read the latest Form 483 and any warning letter. Check whether a warning letter was closed out.
Read the originals
The 483 or warning letter itself, not a summary of it.
Check the outcome
See whether a warning letter was closed out.
Watch the trend
Compare observations across a site's inspections.
Diligence on the record
For a deal, have our team review every site behind the product. For ongoing monitoring, ask your AI tools.
Custom report · best fit
A report from our team
Our team reviews the inspection record of every manufacturing site behind the product and summarises what FDA found, what escalated and what is still open.
Priced per project
Request a custom reportAI connector
Ask in Claude or ChatGPT
Ask Claude or ChatGPT where each site stands with FDA, any time, with the documents linked.
From $78/month, billed yearly
See the AI connectorDocuments
The original documents
Read the original Form 483s and warning letters behind the headline.
From $99 per document
Browse documentsPrefer a REST API? See the API.
Four steps
Name the sites
Company disclosures often list them.
Open each site
By FEI number or name.
Check the outcome
Warning letters and close-outs on each site page.
Read the documents
Buy the 483 or EIR for the inspections that matter.
Questions
Does FDA Intel give investment advice?
No. FDA Intel provides FDA documents and facts about them, not investment advice.
What is a close-out letter?
A letter FDA sends when it has confirmed that the issues in a warning letter were addressed.
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.