US FDA investigator list: where the names come from and how to look one up

A US FDA investigator list is a directory of the FDA field staff who inspect regulated facilities, with each person's inspection record. FDA does not publish one. There is no official public roster of FDA investigators (often called "USFDA auditors"), so every list in use today is rebuilt from the names FDA staff sign on inspection documents, mainly the Form 483.

That is how ours is built. As of our August 15, 2026 release, the Atlas investigator directory holds 4,996 investigator profiles, each linked to the Form 483s and inspections that carry the person's name. This guide shows where the names appear, how to look one up, and what the record tells you before an inspection. Data in this article are from that release, with Form 483s issued through July 2026.

• FDA publishes no roster of its investigators, and the 21 fields of the FDA Data Dashboard citations dataset include the firm's legal name but no investigator name.
• Investigator names appear on four documents an inspected firm receives: the credentials shown on arrival, the Form FDA 482, the Form FDA 483 signature block and the Establishment Inspection Report.
• The Atlas investigator directory (release of August 15, 2026) has 4,996 profiles out of 6,103 names found in inspection records; 1,553 profiles show activity in 2025 or 2026.
• From January 2025 to July 2026, 7,117 Form 483s with observation detail named 1,410 distinct investigators, an average of 1.34 names per form.
• The investigator who signed the most of those forms, a biologics investigator, signed 38: 24 in 2025 and 14 in the first seven months of 2026.

Is there a public list of US FDA investigators?

No. FDA does not publish a public list of its investigators, auditors or inspectors. The agency's Office of Inspections and Investigations (OII), which replaced the Office of Regulatory Affairs on October 1, 2024, publishes organization charts by office, not staff names.

FDA's own inspection data leave the names out too. The citations endpoint of the FDA Data Dashboard has 21 fields, including FEI number, legal name, address, inspection end date, program area and the cited CFR section. None of them identifies an investigator. The Dashboard tells you what was cited at a facility, not who cited it.

The names exist, though, because FDA staff sign their work. Every Form 483 carries the names and titles of the employees who issued it. Collect enough 483s and you can rebuild a list, which is what Atlas, and every other investigator search you will find, has done.

Where do FDA investigator names appear?

FDA investigator names appear on the documents an investigator hands over or signs during and after an inspection. The table shows each one, what it gives you and whether you can get it for an inspection that was not yours.

The Form 483 is the only document that is both public and signed. That is why every investigator directory, ours included, is built from 483s. It also sets the limit: an inspection that ends with no 483 leaves no public trace of who did it. The EIR fills part of that gap for your own facility; FDA sends a copy to the inspected firm once the inspection is closed. How the Form 482 and the 483 close-out work, step by step, is covered in our guide to the FDA Investigations Operations Manual.

How do you look up an FDA investigator by name?

To look up an FDA investigator by name, search the person's surname in the FDA investigator lookup and open the profile that matches the middle initial on your Form 482 or 483. The initial matters. In our directory, a search for "Lisa Flores" returns Lisa L Flores, with 197 inspections, and Lisa W Flores, with 4. They are different people who have inspected together.

Three habits avoid the wrong match:

1. Search the surname alone if the full name returns nothing; FDA forms often print a middle initial that people leave out when they search.
2. Check the latest inspection on the profile against what you know. A profile whose latest inspection on record was in 2021 is unlikely to be your 2026 investigator.
3. Check the product categories. A device investigator rarely leads a sterile injectables inspection.

The directory is free to search. Of the 4,996 profiles, 1,271 hold 100 or more inspections and the median profile holds 34.

What does an FDA investigator profile show?

An FDA investigator profile in Atlas shows the investigator's full public inspection record: total inspections, sites inspected, Form 483 observations attributed to the person, the year their records begin, the product categories they inspect, their most recent inspections with links to each Form 483, and the co-investigators they inspect with most often.

The co-investigator list is the part most teams skip and should not. Investigators often work in pairs or small teams, and a profile shows who shares the most inspections. If your 482 names two people, both profiles are worth reading, and the overlap tells you whether they have worked together before.

Each Form 483 linked from a profile lists the CFR sections cited, observation by observation. Counting those sections across an investigator's recent forms gives you their most-cited regulations, which is how the tables below were built.

Which FDA investigators issue the most Form 483s?

The FDA investigators who issued the most Form 483s in 2025 and 2026 are mostly food and cosmetics investigators, because food facilities receive most 483s. Irina Gaberman, a biologics investigator, leads with 38 forms, followed by Kunapuli T Madhusudhan with 36 and John R Myung with 33.

Method: we counted every Form 483 with observation detail in the Atlas Form 483 directory (release of August 15, 2026) issued from January 1, 2025 to July 20, 2026, 7,117 forms, and credited each form to every investigator named on it. Five investigators tie at 26, so the table has 16 rows.

Thirteen of the 16 work mainly in food and cosmetics. That matches the base rate: of the 4,584 Form 483s issued in 2025, 2,504 went to Foods & Cosmetics facilities, against 807 for devices and 755 for human drugs. A high count reflects workload and program, not severity. Kunapuli T Madhusudhan's 36 forms carry 251 observations, about 7 per form; Roy C Stephens' 28 carry 71, about 2.5 per form. Volume tells you how often a person ends an inspection with a 483. Observations per form tell you how much they write when they do.

No investigator dominates. The top 16 appear on 460 of the 7,117 forms, 6.5%, and the median investigator in 2025 signed 4.

Which FDA investigators do people search for most?

The FDA investigators people search for most by name are mostly human drug and device investigators, many of whom inspect overseas. The eight names below are among the investigator names that brought the most Google searches to Atlas in October 2026. Profile counts are from each Atlas profile; the last two columns count each person's Form 483s issued from January 2025 to July 2026 and the CFR section cited on the most of those forms.

The patterns differ by program. Lisa L Flores' five forms in the period are all at Indian drug manufacturers, including Lupin in Pithampur and Eugia Pharma in Sangareddy, and four of the five cite 211.113, control of microbiological contamination. Saleem A Akhtar's ten forms span India, Switzerland and Turkey, and half cite 211.22, the quality control unit. Nicole E Knowlton's forms are at Florida and North Carolina contract manufacturers, where 211.67, equipment cleaning and maintenance, appears on seven of ten.

The two device investigators cite complaint files (820.198) and corrective and preventive action (820.100) most. Those are Quality System Regulation section numbers; forms issued after the QMSR took effect on February 2, 2026 use the new Part 820 structure, so expect different citations on recent device 483s. Michael Serrano's four recent forms are bioresearch monitoring inspections of sponsors and clinical investigators, which is why they cite Parts 312 and 812 rather than manufacturing rules.

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How do I find out which FDA investigator will inspect my facility?

You find out which FDA investigator will inspect your facility when the investigator arrives, shows credentials and hands over a signed Form FDA 482. FDA does not publish assignments, and most domestic surveillance inspections are unannounced, so for a US facility the 482 is usually the first time you see the name.

There are exceptions. Foreign inspections are normally scheduled ahead with the facility, and the FDA correspondence that sets the dates often names the team, which can give you days or weeks with the name. Pre-announced domestic inspections, such as some pre-approval inspections, work the same way. Since May 2025 FDA has said it will expand unannounced inspections at foreign facilities, so the head start overseas facilities are used to is shrinking.

Either way, the useful window is short. Have your host write down the name and credential number from the credentials and the 482, then look the person up the same day. Your own past EIRs and 483s also tell you who inspected you last; FDA often assigns by program and region, so the same names come back.

How should you use an investigator's record before an inspection?

Use an FDA investigator's record to check your facility against the sections that investigator has actually cited, not to predict a person. Five steps, in order:

1. Confirm the right profile. Match name, middle initial and recent inspection location, as above.
2. Read the last ten Form 483s on the profile. List every CFR section cited and count how often each appears. Two or three sections usually account for most of the record.
3. Compare against your own last inspection. If a section on the investigator's list was also on your last 483, the investigator will check whether it was fixed; have the CAPA evidence ready.
4. Pull records for the top sections. For 211.192, that means open investigations and their timelines; for 211.67, cleaning logs and cleaning validation; for 820.198, the complaint file.
5. Brief the people who will be in the room. Tell the area owners which sections this investigator writes most, and run a short walk-through of those areas as part of your mock inspection.

Keep the use of the record professional. A profile shows where a person has looked before. It is not a guide to the person, and the investigator will follow the compliance program for your product type whatever their history shows. What each profile field means is explained in our earlier piece on FDA investigators and their inspection history, and what the form itself contains is in what an FDA Form 483 is.

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