Pay for what you use.
Your first Form 483 or letter is on us.
Create a free account and pick any document. After that, the prices below apply.
Per-document prices
One price per document type, whatever its length. Prices are in US dollars.
$99
per document
Including amended 483s
The investigator’s inspectional observations, as issued to the firm.
$99
per document
Warning letters, untitled letters, close-out letters, import alerts
FDA’s letter as sent, with every cited violation.
$199
per document
483, warning letter and untitled letter responses
The firm’s written reply: root causes, actions and dates.
$550
per document
Establishment Inspection Reports
The investigator’s full narrative of the inspection.
Every purchase includes
- The original file, ready the moment checkout finishes
- Up to 5 downloads within 30 days
- An invoice PDF with every order
- Download a whole order as one ZIP
- The facts and opening words of each observation before you buy
- Every order kept in your account
Buy several, pay less
Bulk discounts apply automatically when several documents are in one cart. Each file stays its own document.
| Documents in one order | Discount | Example: Form 483s |
|---|---|---|
| 1–4 | Standard price | $99 each |
| 5–9 | 15% off | About $84.15 each |
| 10 or more | 25% off | About $74.25 each |
For example, ten Form 483s cost $742.5 instead of $990.
Site files
Every document for one site, in one purchase.
Site file
Up to 25% offEvery document we have for one site (FEI): its 483s, inspection reports, letters and responses, together in one order, with bulk pricing of up to 25% off. Ideal for supplier qualification and due diligence.
Available now
Find a siteThe AI connector and custom reports
The same intelligence in your AI tools, or as a report our team builds for you.
AI connector subscription
Ask Claude or ChatGPT about any site, investigator or 21 CFR section: FDA inspections, warning letters, import alerts, recalls and registrations, plus our document data and observation previews. The REST API is included.
- Standard $78/month · 1 user10,000 requests a month (up to 1,000 a day)On the annual plan, billed yearly as $935 ($89/month if billed monthly)Start Standard, yearly
- Premium $218/month · up to 3 users50,000 requests a month (up to 5,000 a day)On the annual plan, billed yearly as $2,615 ($249/month if billed monthly)Start Premium, yearly
One request is one tool call in Claude or ChatGPT, or one API call. Usage resets every month. On yearly billing the requests are still a monthly allowance: it resets every month of the year, on the same day of the month as your start date. A top-up adds 10,000 requests for $29, one time. Unused top-up requests end with the current monthly allowance period. Full documents are bought and downloaded separately; the connector covers data, summaries and observation previews.
Need full document text at scale (thousands of documents) through an API? Talk to us.
See plansCustom reports by our team
Our analysts compile everything we hold about your site, your investigator and the regulations that matter, parsed and analysed for you.
Priced per project
Request a custom reportWeighing other options? See all options compared, FDA Intel vs Redica and FDA Intel vs a FOIA request. Questions about a charge? Read the refund policy.
Questions
How much does an FDA Form 483 cost?
$99 per Form 483 on FDA Intel, the same for warning letters, untitled letters, close-out letters and import alerts. Responses are $199 and EIRs $550.
Is there a subscription?
Only for the AI connector. Documents are paid per document by card, with no subscription. The AI connector for Claude, ChatGPT and the API is a subscription billed yearly or monthly, from $78/month, billed yearly ($89 billed monthly). Cancel any time in Account → AI & API: Cancel plan keeps access until the end of the period you paid for, or use Manage billing (the Creem billing portal). Removing the connector from Claude or ChatGPT does not cancel the subscription. Custom reports are priced per project.
How much is the AI connector?
Standard is $78/month on the annual plan (billed yearly as $935) or $89/month billed monthly, for 1 user and 10,000 requests a month (up to 1,000 a day); Premium is $218/month on the annual plan (billed yearly as $2,615) or $249/month billed monthly, for up to 3 users and 50,000 requests a month (up to 5,000 a day). Yearly billing saves about 12%. Both plans are flat prices for the same data and include Claude, ChatGPT and the API. On yearly billing the requests are still a monthly allowance: it resets every month of the year, on the same day of the month as your start date. A top-up adds 10,000 requests for $29, one time. Unused top-up requests end with the current monthly allowance period. Documents are bought separately. Enterprise, larger teams or bulk data: talk to us.
How are custom reports priced?
Per project. Tell us the site, the inspection or the deal and the date you need it by, and we reply with a scope and a fixed price before any work starts.
Is my first document really free?
Yes. Your first Form 483 or letter is on us: create a free account with your work email, verify it, and your first Form 483 or letter costs nothing (EIRs and responses are not included). After that, standard prices apply.
How do bulk discounts work?
Put several documents in one cart and the discount is applied automatically: 15% off 5–9 documents, 25% off 10+ documents.
What do I get after checkout?
The original file, ready to download straight away, up to 5 downloads within 30 days, an invoice PDF for the order, and the option to download a whole order as one ZIP.
What is a site file?
A site file is every document we have for one site (FEI), bought together in one order. Bulk pricing applies automatically: up to 25% off the per-document prices.