FDA Investigator

Karen M Kondas

Latest inspection on record: Cleveland, United States, August 2016 · records back to 2008

BiologicsHuman DrugsMedical Devices & Rad HealthAnimal Drugs & Feeds

FDA inspection record · Last updated July 12, 2026

Overview

  • 180 inspections across 125 sites are on record.
  • 197 Form 483 observations are attributed to this investigator.
  • Most recent recorded activity is 2016-08-25.

At a glance

Inspections

180

Sites

125

Observations

197

Career since

Jan 2008

Recent inspections

Most recent inspections in the published record.

SiteDateCategoryForm 483
Michael J Rosen MD25 Aug 2016Medical Devices & Rad Health
Deren Huang MD PhD4 Aug 2016Human DrugsView 483 →
Nora McNamara28 Jun 2016Human Drugs
Levester Kirksey MD25 May 2016Medical Devices & Rad Health
Charles River Laboratories Cleveland, Inc.6 May 2016Human DrugsView 483 →

Sites inspected

Michael J Rosen MDCleveland, United States1 insp.
Deren Huang MD PhDAkron, United States1 insp.
Nora McNamaraCleveland, United States1 insp.
Levester Kirksey MDCleveland, United States1 insp.
Charles River Laboratories Cleveland, Inc.Cleveland, United States1 insp.

Co-investigators

Investigators who share inspections with this person.

Edward R Kay1 shared
Michael I Gorman1 shared

Full investigator report

Get the verbatim findings behind Karen M Kondas' 197 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