Donald B Ertel - FDA Investigator Report

Designation: Regulatory Officer

Duty Station: Silver Spring MD 20993-0002

Organizations: DHHS FDA CBER CBER OCBQ DMPQ BI

Overview Statistics

17
Total Inspections
13
Total 483s Issued
0
Warning Letters Issued

Inspection Details

Longest Inspection: 9 days
Shortest Inspection: 1 days
Average Length: 4.2 days

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Donald B Ertel's Recent Inspections

DateCompanyCityCountryFEI Number483
2024-08-12Massbiologics South CoastFall RiverUnited States3011802152
2024-07-02Serum Institute of India Pvt. Ltd.PuneIndia3020223359
2023-08-25Charles River Laboratories IncMemphisUnited States3006500433
2022-03-04Kite Pharma, Inc.FrederickUnited States3016888173
2018-08-03Laboratorios Silanes SA de CVTolucaMexico3006664611
2017-06-22SAFC Carlsbad, Inc.CarlsbadUnited States3012673301
2017-06-16KITE PHARMA INCEl SegundoUnited States3012583739
2016-06-16Emergent Biodefense Operations Lansing LLCLansingUnited States1873886
2016-04-22AGC Biologics, Inc.BothellUnited States3000209996
2016-03-28AGC Biologics, Inc.BothellUnited States3000209996

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Donald B Ertel - Co-Inspectors

NameInspectionsLast Inspection
Wei Wang32023
Joan Johnson32016
Prajakta A Varadkar22024
Graeme E Price22022
Michael B Havert22017
Arie Menachem22017
Vanessa Y Jacobs22016
Nicole K Trudel22011
Kinjal S Patel12024
Bo Liang12024
Anissa M Cheung12024
Pankaj H Amin12024
Latorie S Jones12024
Jessica Chery12023
Hoda N Abadeer12023
Zhaohui Ye12023
Phillip C Thai12022
Zhongren Wu12022
Cecily M Jones12018
Michael C Kennedy12018
Kevin P Foley12015
Nancy T Waites12011
Sean R Byrd12010

Donald B Ertel's Active Locations

  • United States
  • Mexico
  • France
  • Denmark
  • India
  • Germany

Donald B Ertel's Year-wise Inspection Count

  • 2010:2 inspections
  • 2011:2 inspections
  • 2014:1 inspections
  • 2015:2 inspections
  • 2016:3 inspections
  • 2017:2 inspections
  • 2018:1 inspections
  • 2022:1 inspections
  • 2023:1 inspections
  • 2024:2 inspections
Last Updated: 2025-05-14 06:11:22