Michael Shanks - FDA Investigator Report

Designation: BIOLOGIST

Duty Station: Silver Spring MD 20993-0002

Organizations: DHHS FDA CDER OMPT CDER OPQ OPF DIA IABI

Overview Statistics

67
Total Inspections
54
Total 483s Issued
0
Warning Letters Issued

Inspection Details

Longest Inspection: 18 days
Shortest Inspection: 1 days
Average Length: 7.5 days

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Michael Shanks's Recent Inspections

DateCompanyCityCountryFEI Number483
2024-08-27Genentech, Inc.OceansideUnited States3006129086
2024-07-12Lonza Biologics, Inc.PortsmouthUnited States3001451441
2024-06-18KBI Biopharma, Inc.DurhamUnited States3004638264
2024-06-17KBI Biopharma, IncDurhamUnited States3017660941
2024-05-28MSD Ireland (Carlow)CarlowIreland3008694906
2024-03-27AGC Biologics, Inc.BothellUnited States3000209996
2024-03-08BioConnection B.V.OssNetherlands3011445650
2024-02-29BSP Pharmaceuticals SpALatinaItaly3007255826
2024-01-19Alvotech HFReykjavikIceland3013702557
2023-11-10Patheon Biologics LLCSaint LouisUnited States3003418999

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Michael Shanks - Co-Inspectors

NameInspectionsLast Inspection
Yi Wang42024
Jacek Cieslak32022
Zhong Li32022
Diane L Raccasi32019
Steven Fong32017
Kamal N Tiwari22024
Ayyappan Rathakrishnan22024
Olumide A Martins22024
Joseph A Piechocki22022
Arsen Karapetyan22022
Lindsey J Brown22021
Alison N Stieg22018
Alice S Tsao22018
Simone E Pitts22018
David A Oluwo22018
Reyes Candau-Chacon22017
Wayne E Seifert22015
Jiangsong Jiang12024
Bingchen Du12024
Jeanne M Fringer12024
Scott C Lute12024
Doan N Singh12024
Hamet M Toure12023
Yun Wu12023
Jill J Tillman12023
Bryan A Galvez12023
Christopher R Czajka12023
Nayan J Patel12023
Ralph M Bernstein12022
Unnee Ranjan12022
Matthew B Casale12022
Michael A Charles12022
Virginia A Carroll12019
Ashley N Queen12019
Santiago Gallardo Johnson12019
Ziyang Su12018
Marion Michaelis12018
Cheryl A Clausen12018
Laura Fontan12018
James M Simpson12018
Lakshmi Ran Narasimhan12017
Scott R Nichols12017
Jessica Hankins12017
Nealie C Newberger12017
Justin A Boyd12017
Jose F Velez12016
Bo Chi12016
Zhihao Pete Qiu12015
Thuy T Nguyen12015

Michael Shanks's Active Locations

  • United States
  • Germany
  • Korea (the Republic of)
  • India
  • Italy
  • Ireland
  • Denmark
  • Switzerland
  • Slovenia
  • China
  • Austria
  • Netherlands
  • Japan
  • South Africa
  • Israel
  • Iceland
  • Poland
  • Australia

Michael Shanks's Year-wise Inspection Count

  • 2015:5 inspections
  • 2016:2 inspections
  • 2017:6 inspections
  • 2018:8 inspections
  • 2019:4 inspections
  • 2020:1 inspections
  • 2021:11 inspections
  • 2022:10 inspections
  • 2023:11 inspections
  • 2024:9 inspections
Last Updated: 2025-05-14 06:11:22