Use case: inspection prep
How to prepare for an FDA inspection with FDA's own documents.
Start with your site's history, read recent Form 483s at sites like yours, check what your investigator cites, and turn it all into a walk-through list.
The short answer
At the end of an inspection, FDA gives the firm a Form 483 listing the investigator's observations and asks for a written response within 15 business days. The best time to learn from other sites' 483s is before your own inspection, while you can still fix what they found.
Read FDA's wording
Real observations tell you what evidence investigators expect to see.
Focus on the most cited
A handful of 21 CFR 211 sections show up in a large share of drug 483s.
Build the walk-through list
Turn the themes into mock-inspection questions and a list of records to have ready.
Let us prepare it with you
Do it yourself with the documents, or have our team build 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.
Priced per project
Request a custom reportDocuments
The original documents
Read your own past 483s and recent 483s at sites like yours, in FDA's words.
From $99 per document
Browse documentsSix steps to inspection readiness
Pull your own history
Search your FEI number and read every past 483 and EIR for your site.
Find peer sites
Filter by program, country and year for sites that make similar products.
Read the observations
Buy the most relevant 483s and note the themes that repeat.
Check the investigator
If you know who is coming, open their profile and see what they cite most.
Check the outcomes
See which inspections led to warning letters and which were closed out.
Run the mock inspection
Turn the themes into questions and a short list of records to have ready.
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 far ahead should I prepare for an FDA inspection?
Start as soon as you expect one. Many routine surveillance inspections come with only a few days' notice, so keep your site's history and a mock-inspection list current all year.
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.
Should I read EIRs as well as 483s?
Yes, when they exist. The EIR is the investigator's full narrative, so it shows what was covered and discussed even when it never became an observation.