FDA Person
FDASean R. Marcsisin
View detailed information about Sean R. Marcsisin, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 73 inspections of 64 companies, 2016–2026.
Inspections (73)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| August 20, 2026 | Baxter Healthcare Corporation | Not classified | Monitoring of Marketed Animal Drugs, Feed, and Devices | #1299166 |
| June 22, 2026 | Brigham and Women's Hospital | Not classified | Drug Quality Assurance | #1323146 |
| May 4, 2026 | Element Materials Technology Boston - Acton Inc. | VAI | Drug Quality Assurance | #1316646 |
| April 9, 2026 | Genzyme Corporation | Not classified | #1294652 | |
| February 6, 2026 | Lonza Biologics, Inc. | Not classified | #1304046 | |
| December 18, 2025 | Shire Human Genetic Therapies, Inc. | Not classified | #1297340 | |
| November 4, 2025 | PETNET Solutions Inc. | VAI | Drug Quality Assurance | #1290272 |
| September 30, 2025 | The General Hospital Corporation | VAI | Generic Drug Evaluation | #1284676 |
| August 8, 2025 | Fagron Compounding Services | Not classified | Drug Quality Assurance | #1273014 |
| July 8, 2025 | Bristol-Myers Squibb Company | Not classified | #1272436 | |
| May 9, 2025 | Apotex Pharmachem Inc. | Not classified | #1269863 | |
| May 2, 2025 | Catalent Ontario Limited | Not classified | Drug Quality Assurance | #1268776 |
| April 25, 2025 | Innocore Sales & Marketing Inc. | OAI | Drug Quality Assurance | #1267971 |
| March 14, 2025 | KVK Tech, Inc. | OAI | Drug Quality Assurance | #1233334 |
| January 17, 2025 | Rentschler Biopharma Inc. | Not classified | #1259307 | |
| November 20, 2024 | N-Molecular Inc. d.b.a. SOFIE | VAI | Drug Quality Assurance | #1250020 |
| September 26, 2024 | ONY Biotech, Inc. | OAI | Drug Quality Assurance | #1250105 |
| July 9, 2024 | Genzyme Corporation | OAI | Drug Quality Assurance | #1232210 |
| May 24, 2024 | Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma Services | VAI | New Drug Evaluation | #1239754 |
| April 4, 2024 | Cipla Limited | VAI | Drug Quality Assurance | #1235546 |
Documents (53)
- 483 · Fagron Compounding Services · August 8, 2025
- 483 · Cipla Limited · April 4, 2024
- 483 · Edge Pharma, LLC · November 30, 2021
- 483 · Zydus Lifesciences Limited · March 27, 2024
- 483 RESPONSE · Foundation Care LLC · March 19, 2013
- EIR · Rentschler Biopharma Inc. · January 17, 2025
- 483 · Bristol-Myers Squibb Company · July 8, 2025
- 483 RESPONSE · N-Molecular Inc. d.b.a. SOFIE · November 7, 2024
- 483 · Shire Human Genetic Therapies, Inc. · December 18, 2025
- EIR · N-Molecular Inc. d.b.a. SOFIE · November 20, 2024
- 483 · Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC · January 17, 2019
- EIR · Genzyme Corporation · June 25, 2022
- EIR · N-Molecular Inc. d.b.a. SOFIE · May 16, 2019
- 483 · N-Molecular Inc. d.b.a. SOFIE · February 28, 2018
- 483 · ONY Biotech, Inc. · September 26, 2024
- EIR · N-Molecular Inc. d.b.a. SOFIE · February 28, 2018
- 483 · The General Hospital Corporation · September 30, 2025
- 483 · Bristol-Myers Squibb Company · July 8, 2025
- 483 · Catalent Ontario Limited · May 2, 2025
- 483 · Pharmasol Corporation · February 10, 2022
- 483 · KVK Tech, Inc. · March 14, 2025
- 483 · Cardinal Health 414 LLC · June 18, 2019
- 483 · Viatris Inc. · July 25, 2019
- 483 · Hikma Pharmaceuticals USA Inc. · November 3, 2023
- 483 · EyePoint Pharmaceuticals, Inc. · February 15, 2024
- 483 · Pharmasol Corporation · June 14, 2021
- 483 · NextPharma OY · September 6, 2022
- 483 · Novo Nordisk US Bio Production Inc. · July 25, 2023
- 483 · PETNET Solutions Inc. · November 4, 2025
- 483 · Edge Pharma, LLC · November 30, 2021
- 483 · Rentschler Biopharma Inc. · January 17, 2025
- 483 · Bolger & O'Hearn Inc · December 19, 2023
- 483 · ALK-Abello, Inc. · March 1, 2019
- 483 · Innocore Sales & Marketing Inc. · April 25, 2025
- 483 · Pharmasol Corporation · June 14, 2021
- 483 · Lumene Oy · August 26, 2022
- 483 · Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma Services · September 27, 2023
- 483 · The Tender Corporation · November 25, 2019
- EIR · Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma Services · December 7, 2018
- 483 · Founders Science Group, LLC · May 17, 2022
- 483 · Genzyme Corporation · July 9, 2024
- 483 · Denison Pharmaceuticals, LLC · February 9, 2023
- 483 · Teva Pharmaceutical Industries Ltd. · May 23, 2023
- 483 · N-Molecular Inc. d.b.a. SOFIE · November 20, 2024
- 483 · Wedgewood Village Pharmacy, LLC · March 24, 2022
- 483 · N-Molecular Inc. d.b.a. SOFIE · May 16, 2019
- 483 · Pharmasol Corporation · August 20, 2018
- 483 · Nippon Sanso Matheson, Inc. · April 5, 2017
- 483 · Genzyme Corporation · March 18, 2026
- 483 · Element Materials Technology Boston - Acton Inc. · May 4, 2026
- 483 · Brigham and Women's Hospital · June 22, 2026
- 483 · Genzyme Corporation · July 25, 2022
- 483 · Safecor Health, LLC · March 16, 2023
Frequently inspected with (10)
Erik W. Koester
Investigator
8 shared
John P. Mistler
Arizona Market President
7 shared
Lori M. Newman
Deputy Director
7 shared
Armen H. Youssoufian
5 shared
Jonathan G. Matrisciano
Program Division Director/District Director
4 shared
Daniel L. Zheng
M.S., Consumer Safety Officer at FDA
3 shared
Robert J. Martin
3 shared
Christina A. Capacci-Daniel
2 shared
Margaret M. Doherty
2 shared
Michael Araneta
issuing_officer
2 shared
Person Information
Name
Sean R. Marcsisin
Title
Senior Consumer Safety Officer - Pharmaceutical Quality
Role
Regulatory Personnel
ID: 45c910a9-9019-4419-9af8-b1c9f3b1e976
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