Steven Fong - FDA Investigator Report

Designation: MICROBIOLOGIST

Duty Station: Silver Spring MD 20993-0002

Organizations: DHHS FDA CDER OMPT CDER OPQ OPF DIA IABI

Overview Statistics

20
Total Inspections
13
Total 483s Issued
0
Warning Letters Issued

Inspection Details

Longest Inspection: 12 days
Shortest Inspection: 3 days
Average Length: 6.5 days

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Steven Fong's Recent Inspections

DateCompanyCityCountryFEI Number483
2019-03-12Kashiv BioSciences, LLCChicagoUnited States3011289655
2018-12-05Abbvie Operations Singapore Pte LtdSingaporeSingapore3011774256
2018-10-26FujiFilm Diosynth Biotechnologies U.S.A., Inc.Research Triangle ParkUnited States3000718852
2018-10-10Alcami Carolinas CorporationCharlestonUnited States1000110990
2018-03-08Rentschler Biopharma SELaupheimGermany1000291122
2018-01-23Toyobo Co. Ltd.OtsuJapan1000251214
2017-08-18Alexion Pharma International Operations Unlimited Co.AthloneIreland3011532960
2017-01-27Amgen Singapore Manufacturing Pte LtdSingaporeSingapore3011255424
2016-11-15Merck Serono SA (Vevey)Corsier-Sur-VeveySwitzerland3003131678
2016-06-06Amgen, Inc.Thousand OaksUnited States2026154

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Steven Fong - Co-Inspectors

NameInspectionsLast Inspection
Michael Shanks32017
Scott R Nichols22018
Bo Chi22017
Reyes Candau-Chacon22017
Vaishali J Patel12019
Ramesh B Potla12019
Rebecca E Dombrowski12019
Amy A Devlin12018
Laurie Nelson12018
V Ashutosh Rao12018
Marion Michaelis12018
Jessica Hankins12017
Diane L Raccasi12017
Ruth A Moore12016
Marcus F Yambot12016
Steven B Hertz12015
Wayne E Seifert12015
Christina A Capacci-Daniel12015
Donald C Obenhuber12014
Denise M Digiulio12014
Mary E Farbman12013
Brenda W Uratani12012
Michelle Y Clark Stuart12012

Steven Fong's Active Locations

  • United States
  • Germany
  • Ireland
  • Switzerland
  • Singapore
  • Japan
  • Korea (the Republic of)
  • France
  • Austria

Steven Fong's Year-wise Inspection Count

  • 2012:2 inspections
  • 2013:1 inspections
  • 2014:2 inspections
  • 2015:4 inspections
  • 2016:3 inspections
  • 2017:2 inspections
  • 2018:5 inspections
  • 2019:1 inspections
Last Updated: 2025-05-14 06:11:22