FDA Investigator

Nigel L Hirth

Latest inspection on record: Bradenburg, Germany, June 2026 · records back to 2022

Human DrugsMedical Devices & Rad HealthBiologicsAnimal Drugs & Feeds

FDA inspection record · Last updated August 15, 2026

Overview

  • 50 inspections across 49 sites are on record.
  • 2 Form 483 observations are attributed to this investigator.
  • Most recent recorded activity is 2026-06-26.

At a glance

Inspections

50

Sites

49

Observations

2

Career since

Jan 2022

Recent inspections

Most recent inspections in the published record.

SiteDateCategoryForm 483
Dr. Isabelle Schenkenberger, M.D.26 Jun 2026Human Drugs
Dr. Yavor Ivanov, M.D., Ph.D.19 Jun 2026Human Drugs
Esther M. H. Nakagawara, O.D.22 May 2026Human Drugs
Carol A. Aune, O.D.15 May 2026Human Drugs
Worldwide Clinical Trials, Inc.5 May 2026Human Drugs

Sites inspected

Dr. Isabelle Schenkenberger, M.D.Bradenburg, Germany1 insp.
Dr. Yavor Ivanov, M.D., Ph.D.Pleven, Bulgaria1 insp.
Esther M. H. Nakagawara, O.D.Garner, United States1 insp.
Carol A. Aune, O.D.Garner, United States1 insp.
Worldwide Clinical Trials, Inc.Research Triangle Park, United States1 insp.

Co-investigators

Investigators who share inspections with this person.

Tracy R Ball2 shared
Talia J Ferguson1 shared
Kerun Hardeo1 shared

Full investigator report

Get the verbatim findings behind Nigel L Hirth's 2 observations

Source 483 PDFs, verbatim observations, and how each site responded, so your team knows what they cite before they arrive.

  • New inspections and Form 483s, mapped to the CFR citation
  • Warning letter outcomes, and the citation patterns they repeat
  • Their co-investigators, so no surprises about who shows up on site