For supplier quality and CMO qualification
Know your supplier's FDA record before you sign.
Look up any manufacturing site and see every Form 483, warning letter and close-out we hold for it. Qualify suppliers on evidence, not on their own summary.
Monitoring many suppliers? Ask about them in Claude or ChatGPT.
Example: Matrix Pharmacorp Private Limited, FEI 3002785310
- Used for
- Supplier qualification
- CMO selection
- Annual supplier reviews
- Quality agreements
- M&A diligence
Your supplier's problems become your problems.
When a contract manufacturer gets a warning letter, your product can be held, your launch slips and FDA asks how you qualified them. A supplier questionnaire tells you what they choose to share. The FDA record tells you what investigators actually found.
See if problems come back
One 483 is a snapshot. Several inspections of the same site show whether fixes held, or whether the same findings return.
Know if it escalated
Did a 483 turn into a warning letter? Was it closed out? The sequence matters more than any single document.
Find the weak systems
See which systems FDA keeps citing, so your audit plan goes straight to the laboratory, the quality unit or the cleanroom.
Charts from the record of Matrix Pharmacorp Private Limited, Vizianagaram, India.
Monitor every supplier, file the full record
Check suppliers' standing from your AI tools whenever you need to, and buy a site's complete file when it goes into the supplier record.
AI connector · best fit
Ask in Claude or ChatGPT
Ask Claude or ChatGPT for any supplier's FDA standing by name or FEI: last inspection and outcome, warning letters and close-outs, import alerts, recalls and registrations, with the documents linked.
From $78/month, billed yearly
See the AI connectorSite file
A site's complete file
Before you qualify, sign or renew: every document we hold for the site in one order, with bulk pricing, for the audit and the quality agreement.
Bulk pricing in one order
See how site files workPrefer a REST API? See the API.
The site file: one order, the whole history.
Every document we hold for a site, as original PDFs, in one order your team can attach to the supplier record. Bulk pricing applies automatically in the cart, up to 25% off.
- Every Form 483, with every observation
- Warning letters and the close-outs that ended them
- An invoice PDF, and one ZIP download for the whole order
Matrix Pharmacorp Private Limited · complete file
4 documents
2 Form 483s1 warning letter1 close-out letter
$396
Cart total for all 4 documents in one order.
Start with the suppliers that carry the most risk
These are the site types where FDA findings most often reach the customers downstream.
Questions
How do I find a supplier's FDA inspection history?
Search by company name or FEI number. The firm page lists every document we hold for that site, in date order, with the investigators and the regulations cited.
What's the difference between a Form 483 and a warning letter?
A Form 483 lists what the FDA investigator observed at the end of an inspection. A warning letter comes later, from FDA itself, when it considers the problems serious and the firm's response inadequate. A close-out letter says FDA is satisfied the warning letter issues were addressed.
Why search by FEI number and not the company name?
One company can run many sites. The FEI number identifies a single site, so you audit the plant that actually makes your material.
Can I share the documents with my team and auditors?
Yes. Documents you buy are yours to keep and use inside your organization, for supplier audits, quality agreements and your supplier file.
Do I get an invoice?
Yes. Every document order comes with an invoice PDF for your records. You pay by card at checkout.
Can I download a whole order at once?
Yes. You can download each document on its own or the whole order as one ZIP file.