For regulatory counsel and law firms
Find the FDA inspection record a matter turns on.
Search by firm, FEI number, investigator or the wording of an observation, and get the original document into your file today.
Every document in the sequence.
A matter often turns on what FDA wrote, when, and how the firm answered. FDA Intel shows the Form 483, the response, the warning letter and the close-out together, by site.
Find the document fast
Search by firm, FEI number, investigator or a phrase from the observation.
Read the sequence of events
See how an inspection, a response and any later letter connect, in date order.
Compare the response
Put the firm's response next to the 483 it answers.
The record, and the research behind it
Get the original documents into your file today, and use the AI connector to research precedent across firms, investigators and citations.
Documents · best fit
The original documents
The original Form 483s, warning letters, responses and close-out letters, with an invoice for the matter.
From $99 per document
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Ask in Claude or ChatGPT
Ask Claude or ChatGPT how FDA cited a regulation across firms, or a company's full inspection and enforcement history, with every document linked.
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The original document, in your file today.
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How legal teams use FDA Intel
Find the site
Search by firm or FEI number.
Read the timeline
Every document for the site, in date order.
Download the originals
With an invoice PDF for the matter.
Questions
What types of FDA documents can I find?
Form 483s, establishment inspection reports (EIRs), 483 and warning letter responses, warning letters and close-out letters. Search by firm, FEI number, investigator or keyword.
What is the difference between a Form 483 and a warning letter?
A Form 483 lists observations at the end of an inspection and is not a final agency decision. A warning letter is a formal FDA notice of violations that asks the firm to correct them.
Does FDA Intel give legal advice?
No. FDA Intel provides FDA documents. How a document applies to a matter is for you and your client to decide.
Do I get an invoice for the matter?
Yes. Every order comes with an invoice PDF, and the whole order can be downloaded as one ZIP file.