Michael F Skelly

FDA Investigator Report

Designation: LEAD PHARMACOLOGIST

Duty Station: Silver Spring MD 20993-0002

Organizations: DHHS FDA CDER OMPT CDER OTS OSIS DGDBE

Total Inspections: 9

Total 483s Issued: 0

Total Warning Letters Issued: 0

Inspection Details

Longest Inspection: 5 days

Shortest Inspection: 4 days

Average Length of Inspection: 4.9 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2020-01-17Regeneron Pharmaceuticals IncTarrytownUnited States1000521995
2019-01-11Celerion IncLincolnUnited States1915582
2018-07-27Bioagilytix LabsDurhamUnited States3007929739
2017-12-08QPS, LLCNewarkUnited States3003581184
2017-05-12Pra Health SciencesAssenNetherlands3012099048
2017-05-04Sanquin Diagnostic ServicesAmsterdamNetherlands3006330919
2017-01-27PPD Bioanalytical LaboratoriesRichmondUnited States1121680
2016-07-22ICON Laboratory Services, Inc.WhitesboroUnited States1319349
2016-01-15Frontage Laboratories, Inc.ExtonUnited States3003542039

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Co-Inspectors

NameInspectionsLast Inspection
Xikui Chen22017
Melkamu Getie Kebtie12020
Iram R Hassan12020
Vickie J Kanion12019
Elise A Murphy12017
Janete F Guardia12016
Yiyue Zhang12016
Karen L Kosar12016
Xiaohan Cai12016
Joseph L Despins12016

Active Locations

Year-wise Inspection Count