Madushini N Dharmasena
FDA Investigator Report
Designation: MICROBIOLOGIST
Duty Station: Silver Spring MD 20993-0002
Total Inspections: 17
Total 483s Issued: 17
Total Warning Letters Issued: 0
Inspection Details
Longest Inspection: 10 days
Shortest Inspection: 4 days
Average Length of Inspection: 8.1 days
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Schedule a DemoRecent Inspections
Date | Company | City | Country | FEI Number | 483 |
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2024-03-08 | CSL Behring (Australia) Pty Ltd | Broadmeadows | Australia | 3001644620 | |
2023-12-14 | Horizon Therapeutics Ireland DAC | Waterford | Ireland | 3020007539 | |
2023-10-12 | DR. REDDY'S LABORATORIES LTD | Hyderabad | India | 3014250111 | |
2023-09-21 | PharmaEssentia Corporation, Taichung Plant | Taichung | Taiwan | 2000012832 | |
2023-05-11 | Pfizer Ireland Pharmaceuticals | Dublin 22 | Ireland | 3004145594 | |
2023-04-21 | UCB Pharma S.A. | Braine-L'Alleud | Belgium | 3003909356 | |
2023-03-16 | Bio-Technology General (Israel), Ltd. | Kiryat Malchi | Israel | 3000164186 | |
2022-11-10 | Synthon Bv | Nijmegen | Netherlands | 3002808298 | |
2022-06-09 | Samsung Biologics Co., Ltd. | Yeonsu | Korea (the Republic of) | 3010479596 | |
2022-03-17 | Alvotech HF | Reykjavik | Iceland | 3013702557 | |
Co-Inspectors
Active Locations
- Ireland
- Korea (the Republic of)
- Japan
- Netherlands
- Switzerland
- Australia
- India
- Belgium
- Iceland
- Singapore
- Israel
- Taiwan
- United States
Year-wise Inspection Count
- 2019: 4 inspections
- 2021: 3 inspections
- 2022: 3 inspections
- 2023: 6 inspections
- 2024: 1 inspections