FAQ
Straight answers before you buy.
Prices, downloads, invoices and the documents themselves, in one place.
Prices and buying
How much does a document cost?
A Form 483 is $99. Warning letters, untitled letters and close-out letters are $99. A 483, warning letter or untitled letter response is $199. An establishment inspection report (EIR) is $550. The price is on every document page before you pay. See pricing
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). One per account. After that, documents are paid one by one.
Is there a subscription?
Not for documents: you pay per document, only for what you need, and nothing renews. The AI connector for Claude, ChatGPT and the API is the one subscription, from $78/month, billed yearly or billed monthly, and you can cancel it at any time.
Do you offer volume discounts?
Yes. Put several documents in one cart: 5 to 9 documents are 15% off, and 10 or more are 25% off. The discount shows in the cart before you pay.
What exactly do I receive?
The original document as a PDF, its content exactly as FDA released it, with searchable text where the scan allows. Each page carries a small FDA Intel mark, your account email and your order code: the copy is for your organization's internal use, not for resale or redistribution. You download it right after checkout and can download it again from your order or account. It is a one-time purchase: nothing renews.
How do I pay?
By card at checkout. You can check out as a guest or with a free account that keeps every order in one place.
Do I get an invoice?
Yes. Every order comes with an invoice PDF for your expenses and records.
Downloads
How quickly do I get the document?
Right away. Downloads start as soon as checkout finishes.
Can I download a document again later?
Yes. Each document can be downloaded up to 5 times within 30 days of purchase, from your order or your account.
Can I download a whole order at once?
Yes. Download each document on its own, or the whole order as one ZIP file.
Can I share documents with my team?
Yes. Documents you buy are yours to keep and use inside your organization.
How do I contact you?
Email info@fdaintel.ai or see the contact page. We reply within one business day.
Documents and search
Where do your documents come from, and is it legal to sell them?
Every document we sell is a U.S. government record that FDA has released to the public under the Freedom of Information Act (FOIA) and related federal disclosure rules. Records made by the federal government are not protected by copyright, and we sell lawfully obtained copies exactly as FDA released them, with FDA's own redactions. We add the searchable text, the extracted details (site, FEI number, dates, investigators, regulations cited) and the summaries.
Which documents can I find?
Form 483s, establishment inspection reports (EIRs), 483 and warning letter responses, warning letters, untitled letters and close-out letters, organized by site, FDA investigator and regulation.
What is a Form 483?
The list of observations an FDA investigator gives a firm at the end of an inspection. It is not a final agency decision. FDA asks for a written response within 15 business days.
What is the difference between a Form 483 and a warning letter?
A Form 483 lists what the investigator observed. A warning letter comes later, from FDA itself, when it considers the problems serious and the response inadequate.
What is an FDA untitled letter?
An enforcement letter from FDA for violations that don't rise to warning-letter level. It has no “Warning Letter” heading, lists what FDA found and asks the firm to reply in writing. We sell the letters and, where we have them, the firm's reply.
What is an EIR?
The establishment inspection report: the FDA investigator's full narrative of an inspection, including what was covered and discussed.
What can I see before I buy?
Each document page shows the firm, site, FEI number, dates, investigators, number of observations and the regulations cited. The document itself comes after purchase.
Can I search by investigator or FEI number?
Yes. Search by firm name, FEI number, FDA investigator or a phrase from an observation.
AI connector and custom reports
Can I use FDA Intel in Claude or ChatGPT?
Yes. The AI connector adds FDA Intel to Claude, ChatGPT and other MCP clients as read-only tools: inspections and outcomes, warning letters, import alerts, recalls, firm and investigator profiles, and our document data. 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. See the AI connector
How do I cancel the AI connector subscription?
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.
Is there an API?
Yes. The REST API is included in both AI connector plans, with a full reference and an OpenAPI spec at /api/docs.
Does the AI connector include the full text of documents?
No. It gives the facts, the summary and the opening words of each observation, with a link to the document. Full documents are bought and downloaded separately on the site.
Do you write reports on a specific investigator or site?
Yes. Our team writes custom reports before an inspection, for a supplier decision or for due diligence: everything we hold on the site and the investigator, analysed for you. Priced per project. Request a custom report