FDA Investigator

Donald L Lech

Latest inspection on record: North York, Canada, October 2019 · records back to 2009

Biologics

FDA inspection record · Last updated July 12, 2026

Overview

  • 5 inspections across 5 sites are on record.
  • 4 Form 483 observations are attributed to this investigator.
  • Most recent recorded activity is 2019-10-11.

At a glance

Inspections

5

Sites

5

Observations

4

Career since

Jun 2009

Recent inspections

Most recent inspections in the published record.

SiteDateCategoryForm 483
Sanofi Vaccines Canada Ltd.11 Oct 2019BiologicsOn file
COSMA Spa10 Jul 2009On file
Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. SPA3 Jul 2009On file
PCAS25 Jun 2009On file
Union Quimico Farmaceutica SA18 Jun 2009On file

Sites inspected

Sanofi Vaccines Canada Ltd.North York, Canada1 insp.
COSMA SpaCiserano, Italy1 insp.
PCASAramon, France1 insp.
Union Quimico Farmaceutica SASant Celoni, Spain1 insp.

Co-investigators

Investigators who share inspections with this person.

Full investigator report

Get the verbatim findings behind Donald L Lech's 4 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