Sean R. Marcsisin
FDA investigator
Appears on 22 documents from 2016 to 2025, most often at sites in Massachusetts. Most often cites equipment cleaning and maintenance (21 CFR 211.67).
- 22
- Documents on file
- 5.6
- Observations per 483
- 2016
- First seen
- 2025
- Most recent
What they cite most
From 122 observations- 21 CFR 211.67Equipment cleaning and maintenance16
- 21 CFR 211.192Production record review14
- 21 CFR 211.113Control of microbiological contamination11
- 21 CFR 211.22Responsibilities of quality control unit11
- 21 CFR 211.42Design and construction features8
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures7
Activity by year
2016: 1, 2017: 3, 2018: 2, 2019: 3, 2021: 1, 2022: 3, 2023: 4, 2024: 3, 2025: 2
Where
Massachusetts 8 · India 2 · New Hampshire 2 · New Jersey 2 · Connecticut 1 · Finland 1
Often inspects with
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Inspection history
22 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-08-08 | 483 Fagron Compounding ServicesAug 8, 2025 · Wichita, Kansas | Wichita, Kansas | 6 | |
| 2025-01-17 | 483 Rentschler Biopharma Inc.Jan 17, 2025 · Milford, Massachusetts | Milford, Massachusetts | 5 | |
| 2024-09-26 | 483 ONY Biotech Inc.Sep 26, 2024 · Amherst, New York | Amherst, New York | 11 | |
| 2024-04-04 | 483 Cipla LtmitedApr 4, 2024 · Raigad, India | Raigad, India | 6 | |
| 2024-03-27 | 483 Zydus Lifesciences LimitedMar 27, 2024 · Matoda, India | Matoda, India | 4 | |
| 2023-11-03 | 483 Hikma Pharmaceuticals USA Inc.Nov 3, 2023 · Cherry Hill, New Jersey | Cherry Hill, New Jersey | 5 | |
| 2023-05-23 | 483 Teva Pharmaceutical Industries Ltd.May 23, 2023 · Kfar Saba, Israel | Kfar Saba, Israel | 5 |
About this profile
What does Sean R. Marcsisin inspect?
Sean R. Marcsisin appears on 22 documents on file covering 21 sites, most often in Massachusetts.
What do they cite most often?
21 CFR 211.67 (equipment cleaning and maintenance), followed by 21 CFR 211.192 and 21 CFR 211.113.
Can I read the observations?
Each document page previews the opening words of every observation. The full documents are available to buy, one at a time or together.
How current is this profile?
The most recent document on file for Sean R. Marcsisin is dated Aug 8, 2025.