Sean R Marcsisin

FDA Investigator Report

Designation: Regulatory Officer

Duty Station: Stoneham MA 02180

Organizations: DHHS FDA ORA OGROP ORA OMPTO OPQO DPQOI PQIBI

Total Inspections: 83

Total 483s Issued: 68

Total Warning Letters Issued: 9

Inspection Details

Longest Inspection: 288 days

Shortest Inspection: 2 days

Average Length of Inspection: 16.7 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2024-09-26ONY Biotech, Inc.BuffaloUnited States1319086
2024-07-09Genzyme CorporationFraminghamUnited States1220423
2024-05-24Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma ServicesBedfordUnited States3008546445
2024-04-04Cipla LimitedRaigadIndia3002806710
2024-03-27Zydus Lifesciences LimitedMatodaIndia3007621329
2024-02-15EyePoint Pharmaceuticals, Inc.WatertownUnited States3005508657
2024-01-18PS-Connections, LLCNorth KingstownUnited States3011444875
2023-12-19Bolger & O'Hearn IncFall RiverUnited States3009509949
2023-11-03Hikma Pharmaceuticals USA Inc.Cherry HillUnited States2220525
2023-09-27Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma ServicesBedfordUnited States3008546445

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Download 483s and EIRs for Sean R Marcsisin

Co-Inspectors

NameInspectionsLast Inspection
Lori M Newman92024
John P Mistler82019
Erik W Koester72024
Armen H Youssoufian42024
Daniel L Zheng42024
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
Paige R Mccoy12024
Karishma G Gopaul12024
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

Active Locations

Year-wise Inspection Count