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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Recent Inspections

DateCompanyCityCountryFEI Number483
2024-03-08CSL Behring (Australia) Pty LtdBroadmeadowsAustralia3001644620
2023-12-14Horizon Therapeutics Ireland DACWaterfordIreland3020007539
2023-10-12DR. REDDY'S LABORATORIES LTDHyderabadIndia3014250111
2023-09-21PharmaEssentia Corporation, Taichung PlantTaichungTaiwan2000012832
2023-05-11Pfizer Ireland PharmaceuticalsDublin 22Ireland3004145594
2023-04-21UCB Pharma S.A.Braine-L'AlleudBelgium3003909356
2023-03-16Bio-Technology General (Israel), Ltd.Kiryat MalchiIsrael3000164186
2022-11-10Synthon BvNijmegenNetherlands3002808298
2022-06-09Samsung Biologics Co., Ltd.YeonsuKorea (the Republic of)3010479596
2022-03-17Alvotech HFReykjavikIceland3013702557

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Download 483s and EIRs for Madushini N Dharmasena

Co-Inspectors

NameInspectionsLast Inspection
Hamet M Toure22023
Maria G Gutierrez-Hoffman12023
Ying Zhang12023
Alice S Tsao12023
Thuy T Nguyen12023
Robert J Ham12023
Cynthia Jim12022

Active Locations

Year-wise Inspection Count