Overview
- 97 inspections across 77 sites are on record.
- 450 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2026-05-04.
At a glance
Inspections
97
Sites
77
Observations
450
Career since
Jul 2016
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Element Materials Technology Boston - Acton Inc. | 4 May 2026 | Human Drugs | On file |
| Genzyme Corporation | 9 Apr 2026 | Human Drugs | On file |
| Lonza Biologics, Inc. | 6 Feb 2026 | Human Drugs | On file |
| Shire Human Genetic Therapies, Inc. | 18 Dec 2025 | Human Drugs | On file |
| PETNET Solutions Inc. | 4 Nov 2025 | Human Drugs | On file |
Sites inspected
Element Materials Technology Boston - Acton Inc.Acton, United States1 insp.
Genzyme CorporationFramingham, United States1 insp.
Lonza Biologics, Inc.Portsmouth, United States1 insp.
Shire Human Genetic Therapies, Inc.Lexington, United States1 insp.
PETNET Solutions Inc.Woburn, United States1 insp.
Co-investigators
Investigators who share inspections with this person.
Lori M Newman12 shared
Erik W Koester9 shared
John P Mistler8 shared
Armen H Youssoufian5 shared
Daniel L Zheng5 shared
Leanna M Slarsky4 shared
Jonathan G Matrisciano4 shared
Robert J Martin3 shared
Ogechi C Nna2 shared
Karen A Briggs2 shared
Full investigator report
Get the verbatim findings behind Sean R Marcsisin's 450 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