For inspection and compliance consultants
FDA's own wording for every client engagement.
Build mock inspections, gap assessments and 483 responses on real observations, and brief clients on the FDA investigator before Day 1.
Realistic findings make realistic mock inspections.
Clients take a mock inspection seriously when the findings read like FDA wrote them. With FDA Intel they did.
Mock findings in FDA's words
Search a topic and use real observations to shape your findings and interview questions.
Brief the client on the investigator
Show what the assigned FDA investigator cites most and where they have inspected.
Support the 483 response
Read how other firms answered similar observations before you help draft your client's.
FDA's record inside every engagement
Use the AI connector to research a client, an investigator or a citation in minutes, and buy the documents you put in front of the client.
AI connector · best fit
Ask in Claude or ChatGPT
Ask Claude or ChatGPT what an investigator cites most, how FDA worded a citation, or a client's full inspection history, with the 483s and letters linked.
From $78/month, billed yearly
See the AI connectorDocuments
The original documents
Buy the Form 483s, warning letters and firm responses you build mock inspections and response templates on.
From $99 per document
Browse documentsPrefer a REST API? See the API.
Your client's next 483 is already written somewhere else.
Find it first, and help them fix it before the inspection.
How consultants use FDA Intel
Pull the client's history
Every past 483 and letter for the client's FEI numbers.
Build the mock inspection
Use real observations on the topics that matter for the site.
Shape the response
Use precedent responses to calibrate root cause and CAPA.
What FDA cites most in drug 483s
Share of drug-manufacturing Form 483s since 2023 that cite each 21 CFR 211 section at least once.
See all regulationsQuestions
How can I use FDA documents in a mock inspection?
Search the topic you are testing, such as cleaning validation or OOS investigations. Read how investigators wrote similar observations, then build your findings and interview questions around that wording.
Can I search by FDA investigator?
Yes. Open the investigator's profile to see the inspections behind the name and what they cite most.
Can I use the documents with clients?
Documents you buy are yours to keep and use in your work. Each order comes with an invoice PDF for your expenses.
Do I need a subscription?
No. Documents are bought one by one, with no subscription. The AI connector for Claude and ChatGPT is a subscription, from $78/month, billed yearly or billed monthly.