For pharma quality and regulatory teams
Walk into your next FDA inspection already knowing the questions.
Read the Form 483s FDA wrote at drug sites like yours, check what your investigator cites most, and fix the gaps while there is still time.
Prepare from the record, not from memory.
Every inspection leaves a paper trail: the Form 483, the EIR, the firm's response and sometimes a warning letter. FDA Intel puts them side by side by site, investigator and regulation, so your team prepares for the inspection FDA actually runs.
Read FDA's own words
See how investigators worded observations on data integrity, OOS investigations or cleaning validation. The wording tells you what evidence to have ready.
Know your investigator
Once you have a name, see what that FDA investigator cites most and where they have inspected.
Write a stronger 483 response
Read how other firms answered similar observations, and how FDA reacted, before you draft your 15-day response.
Three ways QA teams use FDA Intel
Most teams start with a report before a big inspection, read the documents behind it, and keep the AI connector for questions in between.
Custom report · best fit
A report from our team
Before a pre-approval or surveillance inspection, our analysts read your site's history, your likely investigator's record and recent 483s at sites like yours, and tell you what FDA is likely to look at.
Priced per project
Request a custom reportDocuments
The original documents
Read the Form 483s, EIRs and responses FDA wrote at drug sites like yours, in FDA's own words.
From $99 per document
Browse documentsAI connector
Ask in Claude or ChatGPT
Ask Claude or ChatGPT what an investigator cites most, or which 21 CFR 211 sections lead this year, whenever the question comes up.
From $78/month, billed yearly
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One finding you could have seen coming is one too many.
Most 483 observations repeat themes FDA has written up many times before.
How pharma QA teams use FDA Intel
Benchmark your systems
Read recent 483s for your dosage form and note the repeated themes.
Pull your site's history
Every past 483 and EIR for your FEI number, in date order.
Run the mock inspection
Turn the most-cited regulations into questions 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
Is an FDA Form 483 a violation?
No. A Form 483 lists the observations an FDA investigator made during an inspection. It is not a final agency decision. FDA reads your response when it decides whether to take further action, such as 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 of the inspection. QA teams use the 483 to manage the response and the EIR to understand scope.
How do I find similar FDA findings for my response?
Search by keyword, such as data integrity or cleaning validation, and read the matching Form 483s, 483 responses and warning letters. Seeing how similar observations were written and answered helps you size your root cause and corrective actions.
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. Custom reports are priced per project.