Madushini Dharmasena
FDA investigator
Appears on 13 documents from 2019 to 2025, most often at sites in India. Most often cites control of microbiological contamination (21 CFR 211.113).
- 13
- Documents on file
- 5.5
- Observations per 483
- 2019
- First seen
- 2025
- Most recent
What they cite most
From 71 observations- 21 CFR 211.113Control of microbiological contamination23
- 21 CFR 211.192Production record review14
- 21 CFR 211.100Written procedures; deviations8
- 21 CFR 211.160General requirements7
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures5
- 21 CFR 211.42Design and construction features4
Activity by year
2019: 3, 2021: 2, 2022: 2, 2023: 3, 2024: 1, 2025: 2
Where
India 3 · South Korea 2 · Australia 1 · Germany 1 · Iceland 1 · Ireland 1
Often inspects with
Is Madushini Dharmasena coming to your site?
Our team writes custom reports before an inspection: what this investigator cites most, how they write it up, and how your site's history compares, in one brief you can circulate.
Ask about any investigator in Claude or ChatGPT with the AI connector.
Inspection history
13 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-09-12 | 483 Dr. Reddy's Laboratories, LTD, BiologiesSep 12, 2025 · Telangana, India | Telangana, India | 5 | |
| 2025-01-16 | 483 Sanofi-Aventis Deutschland GmbHJan 16, 2025 · Frankfurt am Main, Germany | Frankfurt am Main, Germany | 4 | |
| 2024-03-08 | 483 CSL Behring (Australia) Pty LtdMar 8, 2024 · Broadmeadows, Australia | Broadmeadows, Australia | 4 | |
| 2023-10-12 | 483 DR.REDDY'S LABORATORIES LIMITEDOct 12, 2023 · Bachupally Village, India | Bachupally Village, India | 9 | |
| 2023-10-12 | 483 Dr. Reddy's Laboratories, Ltd.Oct 12, 2023 · Hyderabad, India | Hyderabad, India | 9 | |
| 2023-09-21 | 483 PharmaEssentia Corporation, Taichung PlantSep 21, 2023 · Taichung, Taiwan | Taichung, Taiwan | 9 | |
| 2022-06-09 | 483 Samsung Biologics Co., Ltd.Jun 9, 2022 · Incheon, South Korea | Incheon, South Korea | 3 |
About this profile
What does Madushini Dharmasena inspect?
Madushini Dharmasena appears on 13 documents on file covering 10 sites, most often in India.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.192 and 21 CFR 211.100.
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 Madushini Dharmasena is dated Sep 12, 2025.