FDA investigator profiles
Investigators have patterns. See what yours cites most, where they inspect and who they inspect with, before they walk through your door.
Most active: Justin A. Boyd · Margaret M. Annes · Patty P. Kaewussdangkul
The investigator shapes the inspection.
Every investigator has areas they know best and findings they write up again and again. Knowing that pattern tells you where they'll spend their time, which records they'll ask for first and how they'll phrase what they find. It's the difference between preparing for everything and preparing for what's likely.
“Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process.”
21 CFR 211.113 appears in 60 observations on documents Justin A. Boyd signed, more than any other section.
Know where they'll spend their time
Walk the areas they cite most before they do.
Have the right records ready
Pull the batch records, logs and investigations behind their usual findings.
Brief your team in their language
Show the front-line team how this investigator writes findings up.
What's in every profile
Free to read. Built from the documents themselves: the observations an investigator wrote, the sites they visited and the dates.
What they cite most
The regulations behind their observations, ranked, with plain-English names.
Activity by year
How often they appear on documents, and when they were last seen.
Where they inspect
The states and countries of the sites on their documents.
Who they inspect with
Investigators who appear on the same documents, each linked to their own profile.
Every document
Their inspection history, newest first, with a preview of each observation.
A custom brief from our team
Before an inspection, our analysts write up your investigator's record and how your site compares.
Most active investigators
By number of documents on file. Every name links to a full profile.
Search all investigators- Justin A. Boyd
2010 – 202661 documents - Margaret M. Annes
2007 – 202660 documents - Patty P. Kaewussdangkul
2006 – 202654 documents - Camerson E. Moore
2014 – 202648 documents - Pratik S. Upadhyay
2011 – 202648 documents - Anastasia M. Shields
2016 – 202645 documents - Jose E. Melendez
2001 – 202644 documents - Arsen Karapetyan
2014 – 202543 documents - Stephen D. Brown
2006 – 202142 documents - Eileen A. Liu
2014 – 202641 documents - Erik W. Koester
2006 – 202640 documents - Jeffrey P. Raimondi
2017 – 202640 documents
How teams use profiles
Learn who is coming
When the investigator introduces themselves, or the notice arrives, look them up.
Read their recent 483s
See the systems they focus on and how they phrase what they find, at sites like yours.
Prepare to the pattern
Brief the team, walk the areas they cite most, and have the records ready.
Questions
Are FDA investigator names public?
Yes. Investigators sign the Form 483 they issue at the end of an inspection, and their names appear on it. Profiles group those documents by name.
Can I see which investigator will inspect my site?
FDA doesn't publish assignments in advance. Teams usually learn the name at the start of the inspection or from the inspection notice, then look up the profile.
What does an investigator profile cost?
Profiles are free to read. You pay only for the documents you download. Your first Form 483 or letter is on us.
How current are the profiles?
Each profile shows the year of the most recent document on file for that investigator, and the full history is dated.