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

Overview Statistics

9
Total Inspections
0
Total 483s Issued
0
Warning Letters Issued

Inspection Details

Longest Inspection: 5 days
Shortest Inspection: 4 days
Average Length: 4.9 days

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Michael F Skelly's 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 Development, L.P.RichmondUnited States1121680
2016-07-22ICON Laboratory Services, Inc.WhitesboroUnited States1319349
2016-01-15Frontage Laboratories, Inc.ExtonUnited States3003542039

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Michael F Skelly - 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

Michael F Skelly's Active Locations

  • United States
  • Netherlands

Michael F Skelly's Year-wise Inspection Count

  • 2016:2 inspections
  • 2017:4 inspections
  • 2018:1 inspections
  • 2019:1 inspections
  • 2020:1 inspections
Last Updated: 2025-05-14 06:11:22