FDA Investigator

Sean R Marcsisin

Latest inspection on record: Boston, United States, June 2026 · records back to 2016

Human DrugsAnimal Drugs & FeedsMedical Devices & Rad HealthBiologics

FDA inspection record · Last updated August 15, 2026

Overview

  • 98 inspections across 78 sites are on record.
  • 451 Form 483 observations are attributed to this investigator.
  • Most recent recorded activity is 2026-06-22.

At a glance

Inspections

98

Sites

78

Observations

451

Career since

Jul 2016

Recent inspections

Most recent inspections in the published record.

SiteDateCategoryForm 483
Brigham and Women's Hospital, Inc., The22 Jun 2026Human DrugsView 483 →
Element Materials Technology Boston - Acton Inc.4 May 2026Human DrugsView 483 →
Genzyme Corporation9 Apr 2026Human DrugsOn file
Lonza Biologics, Inc.6 Feb 2026Human DrugsOn file
Shire Human Genetic Therapies, Inc.18 Dec 2025Human DrugsOn file

Sites inspected

Brigham and Women's Hospital, Inc., TheBoston, United States1 insp.
Genzyme CorporationFramingham, United States1 insp.
Lonza Biologics, Inc.Portsmouth, United States1 insp.
Shire Human Genetic Therapies, Inc.Lexington, United States1 insp.

Co-investigators

Investigators who share inspections with this person.

Lori M Newman12 shared
Daniel L Zheng5 shared
Leanna M Slarsky4 shared
Ogechi C Nna2 shared

Full investigator report

Get the verbatim findings behind Sean R Marcsisin's 451 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