Sean R Marcsisin - FDA Investigator Report

Designation: Regulatory Officer

Duty Station: Stoneham MA 02180

Organizations: DHHS FDA ORA OGROP ORA OMPTO OPQO DPQOI PQIBI

Overview Statistics

86
Total Inspections
71
Total 483s Issued
10
Warning Letters Issued

Inspection Details

Longest Inspection: 288 days
Shortest Inspection: 2 days
Average Length: 16.5 days

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Sean R Marcsisin's Recent Inspections

DateCompanyCityCountryFEI Number483
2025-03-14KVK Tech, Inc.NewtownUnited States3005117563
2025-01-17Rentschler Biopharma Inc.MilfordUnited States3003282293
2024-11-20N-Molecular Inc. d.b.a. SOFIEHaverhillUnited States3005693151
2024-09-26ONY Biotech, Inc.AmherstUnited States1319086
2024-07-09Genzyme CorporationFraminghamUnited States1220423
2024-05-24Lyophilization Services of New England, Inc.BedfordUnited States3008546445
2024-04-04Cipla LimitedRaigadIndia3002806710
2024-03-27Zydus Lifesciences LimitedMatodaIndia3007621329
2024-02-15EyePoint Pharmaceuticals, Inc.WatertownUnited States3005508657
2024-01-18PS-Connections, LLCNorth KingstownUnited States3011444875

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Sean R Marcsisin - Co-Inspectors

NameInspectionsLast Inspection
Lori M Newman102024
John P Mistler82019
Erik W Koester72024
Daniel L Zheng52025
Armen H Youssoufian42024
Leanna M Slarsky42022
Jonathan G Matrisciano42018
Robert J Martin32018
Ogechi C Nna22024
Karen A Briggs22023
Michael Araneta22023
Samir C Gala22021
Jonah S Ufferfilge22019
Margaret M Sands22018
Christina A Capacci-Daniel22018
Edmund F Mrak22018
Nealie C Newberger22017
Divek R Jumani12025
Michael O Idowu12025
Syeda N Mahazabin12025
Paige R Mccoy12024
Karishma G Gopaul12024
James R Birkenstamm12024
Adetutu M Gidado12024
Samuel J Arsenault12023
Lane V Christensen12023
Jeffrey J Thibodeau12023
Amy N Chen12022
Kristina L Conroy12022
Kathleen M Jordan12020
Lauren N Barber12020
Jee Y Chung12019
Thomas J Arista12019
Zhongren Wu12019
Guerlain Ulysse12019
Tamil Arasu12019
Christopher Janik12018
Sharmista Chatterjee12017
Yong Hu12017
Christopher D Downey12017
Yanming An12017
Debra M Emerson12017
Arie Menachem12017
Stacey S Degarmo12016
Kenneth H Williams12016
Vioela J Caze12016
Justine M Corson12016

Sean R Marcsisin's Active Locations

  • United States
  • India
  • Finland
  • Canada
  • Switzerland
  • Sweden
  • Norway
  • Germany
  • Belgium
  • Israel
  • United Kingdom
  • Poland

Sean R Marcsisin's Year-wise Inspection Count

  • 2016:8 inspections
  • 2017:13 inspections
  • 2018:15 inspections
  • 2019:12 inspections
  • 2020:2 inspections
  • 2021:6 inspections
  • 2022:11 inspections
  • 2023:9 inspections
  • 2024:8 inspections
  • 2025:2 inspections
Last Updated: 2025-05-14 06:11:22