FDA Investigator

Miriam M Ngundi

Latest inspection on record: Elkton, United States, November 2025 · records back to 2022

Biologics

FDA inspection record · Last updated July 12, 2026

Overview

  • 8 inspections across 7 sites are on record.
  • 0 Form 483 observations are attributed to this investigator.
  • Most recent recorded activity is 2025-11-21.

At a glance

Inspections

8

Sites

7

Observations

0

Career since

May 2022

Recent inspections

Most recent inspections in the published record.

SiteDateCategoryForm 483
Merck Sharp & Dohme LLC21 Nov 2025Biologics
Axogen Corp29 Apr 2025BiologicsOn file
Neurotech Pharmaceuticals, Inc.26 Jul 2024BiologicsOn file
Biotest Ag15 Dec 2023BiologicsOn file
GenIbet Biopharmaceuticals31 Jan 2023BiologicsOn file

Sites inspected

Merck Sharp & Dohme LLCElkton, United States1 insp.
Axogen CorpVandalia, United States1 insp.
Neurotech Pharmaceuticals, Inc.Cumberland, United States1 insp.
Biotest AgDreieich, Germany1 insp.
GenIbet BiopharmaceuticalsOeiras, Portugal1 insp.

Co-investigators

Investigators who share inspections with this person.

Kathleen R Jones3 shared
Neetu Dahiya2 shared
Lori P Peters2 shared
Wen J Seeto1 shared
Jin S Hong1 shared
Kyung E Sung1 shared
Carolina Panico1 shared
Alyssa N Kitchel1 shared
Lu Deng1 shared
Nicole M Li1 shared

Full investigator report

Get the verbatim findings behind Miriam M Ngundi's inspection record

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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