Use case: supplier due diligence
Check a supplier's FDA inspection record before you qualify it.
Start every supplier audit from the FEI number, read the site's documents in order, and see whether problems were fixed or came back.
The short answer
FDA identifies each site by its FDA Establishment Identifier (FEI). Start from the FEI, not the company name, because one company can run many sites. Then read the site's Form 483s, warning letters and close-outs in date order.
See if problems come back
Compare observations across inspections of the same site.
Know if it escalated
Check for warning letters, and for the close-out letter that ended one.
Aim the audit
Go straight to the systems FDA keeps citing at that site.
Charts from the record of Matrix Pharmacorp Private Limited, Vizianagaram, India.
Monitor suppliers, file the record
Check every supplier's standing from your AI tools, and put the complete site file in the supplier record before you qualify it.
AI connector · best fit
Ask in Claude or ChatGPT
Ask Claude or ChatGPT for a supplier's FDA standing by FEI: inspections and outcomes, warning letters and close-outs, import alerts and recalls.
From $78/month, billed yearly
See the AI connectorSite file
A site's complete file
Every document we hold for the site in one order, with bulk pricing, for your audit and quality agreement.
Bulk pricing in one order
See how site files workPrefer a REST API? See the API.
Five steps for a supplier check
Get the FEI number
Ask the supplier, or search the company name and pick the right address.
Open the site page
Review its documents by year.
Check for warning letters
A close-out letter means FDA accepted the corrections.
Read the latest 483
And the firm's response, if there is one, to see what it committed to.
File the evidence
Attach the documents and the invoice PDF to the supplier record.
A real site file
Here is the record we hold for Matrix Pharmacorp Private Limited in Vizianagaram, India: every document for the site in one order, with bulk pricing up to 25% off.
Matrix Pharmacorp Private Limited · complete file
4 documents
2 Form 483s1 warning letter1 close-out letter
$396
Questions
What is an FEI number?
The FDA Establishment Identifier: a number FDA gives each registered site. It keeps one plant's inspection record apart from the rest of the company.
Is one Form 483 a reason to drop a supplier?
Usually not on its own. Look at the whole record: how many inspections, whether findings repeat, and whether any warning letter was closed out.
Can I download a supplier's whole file at once?
Yes. Put the site's documents in one order and download them as a single ZIP file, with an invoice PDF.