Where Can You Find FDA Inspector Details and Inspection Patterns?
FDA inspections are never random. Every inspector has their own way of working, some focus more on documentation, others on CAPA systems, while some might dig deep into your lab practices.
If you're part of a quality assurance (QA), regulatory affairs, or compliance team, the biggest question before an inspection is:
What will the FDA inspector look at, and how can we be ready in advance?
The good news is: You can now find answers to that.
Thanks to tools like Atlas Compliance, you can access detailed data on FDA inspectors, their past inspection history, and their behavior patterns all in one place.
Why Knowing Inspector Behavior Matters
Let’s say you're told that a particular FDA officer is coming to inspect your facility.
Wouldn’t you want to know:
How many inspections they’ve done?
What they usually issue Form 483s for?
How long their average inspections last?
If they’ve issued many warning letters in your industry?
This kind of knowledge can help your team prepare much better and avoid unexpected surprises.
What Information Can You Find in Atlas?
Atlas is a regulatory intelligence platform that offers a detailed database of FDA inspections, inspectors, citations, and more. Here's how it helps:
Inspector’s full name and contact details
Years of experience (e.g., active since 2008)
Total number of inspections they’ve done
Countries where they’ve audited (e.g., U.S., India, China, Vietnam)
Number of 483s and warning letters they’ve issued
This helps you understand how experienced the inspector is and how strict they might be.
Company names they inspected
Industry type (pharma, food, cosmetics, etc.)
Whether a Form 483 or Warning Letter was issued
Inspection classification (e.g., NAI, VAI, OAI)
Number of days spent on-site
This helps you understand what kind of issues this inspector usually finds and how long they typically inspect.
You can also access the exact citations an inspector has used in past audits.
For example, if an inspector often cites 21 CFR 211.192 (investigation of discrepancies), then you know to double-check your deviation records.
This allows your QA team to focus on high-risk areas before the inspection.
Some FDA inspections involve more than one officer. Atlas shows you which inspectors often work together.
Knowing this helps you prepare for multi-inspector audits.
You can download real FDA documents such as:
Establishment Inspection Reports (EIRs)
These documents are valuable for internal training, benchmarking, and root cause analysis.
Atlas shows charts and graphs for:
Number of inspections by year
How many times 483s were issued
Most common CFR citations
Inspection behavior trends
This helps you understand if the regulatory focus is shifting (for example, from CAPA to data integrity).
This feature uses artificial intelligence to give smart suggestions:
Predicts what an inspector might focus on
Shows common risk areas based on past findings
Gives hints like “check CAPA” or “review batch records”
It’s like having an AI-based checklist customized for your inspector.
Real Example: Lesley Swanson
Lesley Swanson is a real FDA inspector. Using Atlas, we can learn:
She has completed 203 inspections
She has issued 80 Form 483s
7 warning letters were given based on her audits
She inspects in countries like the U.S., India, China, Peru, and more
Her average inspection lasts 5.29 days
Wouldn’t it be useful to know all this before she visits your facility?
How Atlas Helps Your QA & RA Teams
Here’s what teams can do using Atlas:
✔ Train staff using real inspection patterns
✔ Review citations before inspections
✔ Prepare documentation based on actual FDA trends
✔ Avoid repeated mistakes from past audits
✔ Save hours of manual research by using one dashboard
What’s Next for FDA Audit Prep?
Regulations are getting stricter. Inspectors are relying more on data. Inspections are now more remote, risk-based, and data-driven.
This means your prep also needs to be smarter, not just more paperwork, but better tools.
Atlas is not just a platform. It’s a strategic advantage.
You don’t need to guess what your next FDA inspector is going to look for.
With Atlas, you can prepare based on facts, trends, and real inspection data.
Because when you know more, you risk less.
Frequently Asked Questions
1. Why should I care about who my FDA inspector is?
Knowing your inspector helps you prepare better. Each inspector has patterns, some issue more 483s, some focus more on documentation. If you know what they usually look for, you can get ahead of the risk.
2. Can Atlas really show me the full inspection history of an FDA officer?
Yes. Atlas gives you details like the number of inspections an officer has done, how often they issue 483s or warning letters, how long their inspections usually last, and which countries they've worked in. It’s like getting a sneak peek before the real show begins.
3. How do I know what specific issues an inspector usually finds?
Atlas pulls citation data and shows what sections of the CFR (Code of Federal Regulations) the inspector often refers to. This helps you understand exactly what they flag most.
