FDA Investigator

Nigel L Hirth

Latest inspection on record: Garner, United States, May 2026 · records back to 2022

Human DrugsMedical Devices & Rad HealthBiologicsAnimal Drugs & Feeds

FDA inspection record · Last updated July 12, 2026

Overview

  • 48 inspections across 47 sites are on record.
  • 2 Form 483 observations are attributed to this investigator.
  • Most recent recorded activity is 2026-05-22.

At a glance

Inspections

48

Sites

47

Observations

2

Career since

Jan 2022

Recent inspections

Most recent inspections in the published record.

SiteDateCategoryForm 483
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
Syneos Health Inc.27 Apr 2026Human DrugsOn file
Catalyst Clinical Research16 Jan 2026Medical Devices & Rad Health

Sites inspected

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.
Syneos Health Inc.Morrisville, United States1 insp.
Catalyst Clinical ResearchWilmington, United States1 insp.

Co-investigators

Investigators who share inspections with this person.

Michelle D Haamid3 shared
Tracy R Ball2 shared
Talia J Ferguson1 shared
Kerun Hardeo1 shared
Mishelle L Harriger1 shared
Donna D Gallien1 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

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