FDA Investigator

Dorothy W Lee

Latest inspection on record: Solna, Sweden, March 2015 · records back to 2010

Medical Devices & Rad Health

FDA inspection record · Last updated July 12, 2026

Overview

  • 18 inspections across 18 sites are on record.
  • 96 Form 483 observations are attributed to this investigator.
  • Most recent recorded activity is 2015-03-31.

At a glance

Inspections

18

Sites

18

Observations

96

Career since

Oct 2010

Recent inspections

Most recent inspections in the published record.

SiteDateCategoryForm 483
Cepheid Ab31 Mar 2015Medical Devices & Rad HealthView 483 →
Bioprod D.O.O.26 Mar 2015Medical Devices & Rad HealthView 483 →
DiaSorin Ireland Ltd.10 Apr 2014Medical Devices & Rad HealthView 483 →
Medinol Ltd.31 Mar 2014Medical Devices & Rad HealthView 483 →
Medinol Ltd.27 Mar 2014Medical Devices & Rad HealthView 483 →

Sites inspected

Cepheid AbSolna, Sweden1 insp.
Bioprod D.O.O.Ljubljana, Slovenia1 insp.
DiaSorin Ireland Ltd.Dublin, Ireland1 insp.
Medinol Ltd.Tel Aviv, Israel1 insp.
Medinol Ltd.Jerusalem, Israel1 insp.

Co-investigators

Investigators who share inspections with this person.

Full investigator report

Get the verbatim findings behind Dorothy W Lee's 96 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