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

Discover the bigger picture. This is just the tip of the iceberg.

Gain access to comprehensive analysis, detailed reports, AI assistant, and much more.

Schedule a Demo

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

Sign Up to get the complete report.

Download 483s and EIRs for Michael Shanks

Michael Shanks - Co-Inspectors

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