For investors and analysts
Read the FDA inspection record behind the headline.
When a company mentions an inspection, find the site and read the Form 483 or warning letter itself. Form your own view from the original.
The document, not the press release.
Company statements summarize. The Form 483 and the warning letter say exactly what FDA found, at which site and when.
Go to the source document
Read the 483, warning letter or close-out letter in full, as FDA issued it.
See the sequence
Follow a site from inspection to warning letter to close-out, in date order.
Check the sites behind a company
Search manufacturing sites and partners by name or FEI number.
Check the sites behind the story
Screen the manufacturing sites across a portfolio from your AI tools, commission a report when a deal depends on one, and read the originals.
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Ask Claude or ChatGPT where each site in a portfolio stands with FDA: last inspection, OAI outcomes, open warning letters, import alerts and recalls.
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A report from our team
For a deal or a decision date, our team reviews the record of every site behind the product and summarises what FDA found and what is still open.
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The original documents
Read the Form 483 or warning letter itself, not the press release.
From $99 per document
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An unresolved warning letter can hold up an approval.
Know where each site stands before the decision date.
How analysts use FDA Intel
Name the sites
Company filings often list the manufacturing sites.
Read each site's record
483s, warning letters and close-outs, in date order.
Form your own view
Use the original text, not a summary of it.
Questions
Is an FDA Form 483 a violation?
No. A Form 483 lists observations made during an inspection. It is not a final agency decision. The firm may respond, and FDA may take further action or none.
How is a warning letter different from a Form 483?
A Form 483 records observations at the end of an inspection. A warning letter is a formal FDA notice of significant violations. A close-out letter comes after FDA finds the issues in a warning letter addressed.
Does FDA Intel give investment advice?
No. FDA Intel provides FDA documents and facts about them. It gives no ratings, forecasts or investment views.
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.