The FDA 483 database and inspection documents.
From $99 per document.
Your first Form 483 or letter is on us. No subscription. Instant PDF download.
What you can buy
Six kinds of FDA inspection document, each matched to its firm, site, investigator and the regulations cited.
The investigator’s list of inspectional observations, handed to the firm at the end of an inspection.
See exactly what FDA cited, in FDA’s own words.
About Form 483sThe investigator’s full narrative of the inspection: scope, records reviewed, findings and the discussion with management.
The deepest view of how an investigator works a site.
About EIRsThe firm’s written reply to a 483, warning letter or untitled letter: root causes, corrective actions and dates.
Precedent for writing your own response.
About responsesFDA’s formal notice that it found significant violations, with each one listed and what FDA expects next.
The clearest signal of a site’s compliance risk.
About warning lettersAn FDA letter about violations that do not rise to a warning letter, often on promotion or labeling.
Early signs of where FDA is paying attention.
About untitled lettersFDA’s confirmation that a firm has addressed the violations in a warning letter.
Shows how, and how fast, a site resolved a problem.
Search close-out lettersNeed the whole picture?
Buy a site’s complete file, or several documents at once, and the discount applies automatically.
Complete site file
Up to 25% offEvery document we hold for one site (FEI): its 483s, inspection reports, letters and responses, in one order. Ideal for supplier qualification and due diligence.
Find a siteBuy several, pay less
- 1–4 documentsStandard price
- 5–9 documents15% off
- 10 or more documents25% off
How it works
- 1Search freeBy firm, FEI number, investigator, regulation or the words FDA used.
- 2See what’s insideThe facts and the opening words of each observation, before you pay.
- 3Download the originalThe full PDF the moment checkout finishes, yours to keep.
Want the data inside Claude or ChatGPT? See the AI connector. Need it analysed for you? Request a custom report.
Questions
What does a document cost?
$99 for a Form 483, warning letter, untitled letter or close-out letter; $199 for a response; $550 for an inspection report (EIR). One price per type, whatever the length.
Is there a subscription?
Not for documents: you pay per document by card. If you want the data inside Claude, ChatGPT or your own systems, that is the separate AI connector subscription: it covers data, summaries and observation previews, not the documents themselves.
Is this an FDA 483 database?
Yes. Every Form 483 we hold is searchable by firm, FEI number, investigator, date, place, cited 21 CFR section and the words of the observations, with the facts and the opening words of each observation shown before you buy.
What is a site file?
Every document we hold for one site (FEI), bought together in one order. Bulk pricing applies automatically: 15% off 5+ documents, 25% off 10+ documents.
What do I get after checkout?
The original file, ready straight away, up to 5 downloads within 30 days, an invoice PDF and the option to download a whole order as one ZIP.
Find the document you need.
Your first Form 483 or letter is on us. No subscription, no sales call.
Search documents