Nicole K Trudel - FDA Investigator Report

Designation: QUALITY ASSURANCE SPECIALIS

Duty Station: Silver Spring MD 20993-0002

Organizations: DHHS FDA CBER CBER OCBQ DMPQ

Overview Statistics

13
Total Inspections
11
Total 483s Issued
0
Warning Letters Issued

Inspection Details

Longest Inspection: 8 days
Shortest Inspection: 1 days
Average Length: 2.1 days

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Nicole K Trudel's Recent Inspections

DateCompanyCityCountryFEI Number483
2015-11-04Telesta Therapeutics Inc.Pointe-ClaireCanada3011214677
2014-04-08N.V. OrganonOssNetherlands3002806821
2014-03-31Broekman InstituteSomerenNetherlands3009390218
2014-03-28Tjoapack Netherlands BVEtten-LeurNetherlands3010418451
2013-05-08Bora Pharmaceuticals Injectables IncBaltimoreUnited States1000512361
2012-03-02Duke Medical Center-Carolinas Cord Blood Bank and Stem Cell LaboratoryDurhamUnited States3002663011
2011-02-15Sanofi Winthrop IndustrieLe TraitFrance3003259844
2010-11-18Sanofi Pasteur Inc.SwiftwaterUnited States2518760
2010-06-24Maxim Biomedical Inc.RockvilleUnited States1122236
2009-08-07Wyeth Lederle VaccinesSanfordUnited States3000719104

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Nicole K Trudel - Co-Inspectors

NameInspectionsLast Inspection
Richard H Coats32014
Donald B Ertel22011
Kevin P Foley12015
Michael J Vardon12013
Quyen T Tran12013
Nancy T Waites12012
Qiao Y Bobo12010
Lori P Peters12010
Joseph George12009
Sarah B Tanksley12009
Paula A Trost12008
Joyce A Rockwell12008
Deborah M Trout12008
Joey V Quitania12008

Nicole K Trudel's Active Locations

  • United States
  • Netherlands
  • Italy
  • Canada
  • France

Nicole K Trudel's Year-wise Inspection Count

  • 2008:2 inspections
  • 2009:2 inspections
  • 2010:2 inspections
  • 2011:1 inspections
  • 2012:1 inspections
  • 2013:1 inspections
  • 2014:3 inspections
  • 2015:1 inspections
Last Updated: 2025-05-14 06:11:22