FDA Investigator

Karen J Bak

Latest inspection on record: Fresno, United States, March 2024 · records back to 2008

BiologicsFoods & CosmeticsHuman DrugsMedical Devices & Rad HealthAnimal Drugs & Feeds

FDA inspection record · Last updated July 12, 2026

Overview

  • 314 inspections across 229 sites are on record.
  • 310 Form 483 observations are attributed to this investigator.
  • Most recent recorded activity is 2024-03-01.

At a glance

Inspections

314

Sites

229

Observations

310

Career since

Jan 2008

Recent inspections

Most recent inspections in the published record.

SiteDateCategoryForm 483
Central California Blood Center1 Mar 2024Biologics
Central California Blood Center14 Feb 2024Biologics
Valley Andrology Fertility Center Inc.18 Jan 2024Biologics
American National Red Cross, The18 Oct 2023Biologics
Pacific Medical Inc4 Oct 2023Biologics

Sites inspected

Central California Blood CenterFresno, United States1 insp.
Central California Blood CenterVisalia, United States1 insp.
Valley Andrology Fertility Center Inc.Clovis, United States1 insp.
American National Red Cross, TheOakland, United States1 insp.
Pacific Medical IncFresno, United States1 insp.

Co-investigators

Investigators who share inspections with this person.

Full investigator report

Get the verbatim findings behind Karen J Bak's 310 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