FDA Investigator

Claire M Minden

Latest inspection on record: Round Lake, United States, September 2022 · records back to 2008

Human DrugsBiologicsFoods & CosmeticsAnimal Drugs & FeedsMedical Devices & Rad Health

FDA inspection record · Last updated July 12, 2026

Overview

  • 265 inspections across 216 sites are on record.
  • 591 Form 483 observations are attributed to this investigator.
  • Most recent recorded activity is 2022-09-15.

At a glance

Inspections

265

Sites

216

Observations

591

Career since

Jan 2008

Recent inspections

Most recent inspections in the published record.

SiteDateCategoryForm 483
BAXALTA US INC.15 Sep 2022BiologicsView 483 →
Patheon Manufacturing Services LLC4 Aug 2022BiologicsView 483 →
Serum Institute of India Private Ltd.19 Apr 2022BiologicsOn file
Merck Teknika LLC23 Feb 2022Biologics
Catalent Maryland Inc17 Nov 2021BiologicsOn file

Sites inspected

BAXALTA US INC.Round Lake, United States1 insp.
Patheon Manufacturing Services LLCGreenville, United States1 insp.
Merck Teknika LLCDurham, United States1 insp.
Catalent Maryland IncHarmans, United States1 insp.

Co-investigators

Investigators who share inspections with this person.

Diana M Guidry3 shared
Ademola O Daramola2 shared

Full investigator report

Get the verbatim findings behind Claire M Minden's 591 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