For quality and inspection readiness teams
Prepare for the inspection FDA is actually going to run.
Read the Form 483s FDA wrote at sites like yours, see what your investigator cites, and walk the floor with that list in hand.
Fix it before it's written up.
FDA Intel puts the documents FDA writes during and after inspections in one place: Form 483s, inspection reports, warning letters and firm responses, organized by site, investigator and regulation. You see what FDA looks for, in its own words, while there's still time to act.
Read it in FDA's words
The observations investigators actually wrote, not someone's summary. The wording tells you what evidence they wanted to see.
See the pattern
What gets cited at sites like yours, and by the investigator assigned to you. Prepare for the likely findings, not every possible one.
Act before Day 1
Turn other sites' findings into your own walk-through list, and close the gaps while the inspection is still on the calendar.
Prepare yourself, or have us prepare it with you
Most teams read the documents themselves. When an inspection matters most, our team writes the brief.
Custom report · best fit
A report from our team
Our analysts read your site's history, your likely investigator's record and recent 483s at sites like yours, and give you a written brief of what FDA is likely to look at, before Day 1.
Priced per project
Request a custom reportDocuments
The original documents
Your site's past 483s and recent 483s at sites like yours, as the original documents, priced per document.
From $99 per document
Browse documentsAI connector
Ask in Claude or ChatGPT
Between inspections, ask Claude or ChatGPT what an investigator cites most or which sections FDA cites at sites like yours.
From $78/month, billed yearly
See the AI connectorPrefer a REST API? See the API.
A 483 is permanent. Customers, partners and investors will read yours.
The best time to prevent one is before the investigator arrives.
Four steps from notice to Day 1
A simple routine your team can run the week the inspection notice lands.
Pull your own history
Your site's past 483s. What was cited last time is the first thing the investigator checks.
Read sites like yours
Recent 483s for the same product type and systems, in FDA's exact words.
Profile the investigator
What they cite most, how long their inspections run and who they inspect with.
Walk the floor with the list
Turn the observations into a mock-inspection checklist for each area.
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 regulationsStart with your product type
Open recent Form 483s for sites that make what you make.
Questions
How do I prepare for an FDA inspection?
Start with your own past Form 483s. Then read recent 483s at similar sites, check what your FDA investigator cites most, and run a mock inspection against the most-cited regulations. Close the gaps before Day 1.
What does FDA cite most in drug manufacturing inspections?
Production record review (21 CFR 211.192) and responsibilities of the quality control unit (21 CFR 211.22) each appear in about four in ten drug-manufacturing 483s since 2023.
What is a Form 483?
The list of observations an FDA investigator hands to a firm at the end of an inspection. FDA asks for a written response within 15 business days. A 483 is not a final finding, but FDA reads the response when it decides on a warning letter.
What is the difference between a Form 483 and an EIR?
The Form 483 lists what the investigator observed. The establishment inspection report (EIR) is the investigator's full narrative: what was covered, who was interviewed and what was discussed. Together they show what FDA looked at and what it wrote up.
Can a 483 lead to a warning letter?
Yes. If FDA considers the observations serious and the response inadequate, it can issue a warning letter. Warning letters are posted and often read by customers, partners and investors.