Xikui Chen - FDA Investigator Report

Designation: PHARMACOLOGIST

Duty Station: Silver Spring MD 20993-0002

Organizations: DHHS FDA CDER OMPT CDER OTS OSIS DGDBE

Overview Statistics

34
Total Inspections
10
Total 483s Issued
0
Warning Letters Issued

Inspection Details

Longest Inspection: 12 days
Shortest Inspection: 1 days
Average Length: 4.3 days

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Xikui Chen's Recent Inspections

DateCompanyCityCountryFEI Number483
2023-07-28QUOTIENT SCIENCES (ALNWICK) LIMITEDAlnwickUnited Kingdom3008798339
2023-06-09AnaZeal Analyticals & Research Pvt LtdNavi MumbaiIndia3006441076
2023-04-21Sciegen Pharmaceuticals IncHauppaugeUnited States3008298016
2020-02-07SPS Pharma ServicesOrleansFrance3009886271
2020-01-31Enem Nostrum Remedies Pvt. LtdMumbaiIndia3012082928
2019-11-15NDI ADRL Inc. dba Diteba Research Laboratories Inc.MississaugaCanada3005415167
2019-10-18Alkem Laboratories LtdNavi MumbaiIndia3004438419
2019-10-11Mylan Laboratories LtdHyderabadIndia3006355432
2019-08-16Sinotherapeutics Inc.ShanghaiChina3011691239
2019-03-21Aurigene Discovery Technologies Ltd.HyderabadIndia3003624249

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Xikui Chen - Co-Inspectors

NameInspectionsLast Inspection
Melkamu Getie Kebtie42020
Sripal R Mada42018
Mohsen Rajabi Abhari32019
Li-Hong Yeh22019
Michael F Skelly22017
Joanne M Schlossin22014
Gulshan R Anand22014
John A Iwen22011
Matthew R Palo22010
Craig A Garmendia12020
Susanne M Richardson12018
Courtney N Long12017
Jennifer C Adams12017
Hasan A Irier12016
Nicola M Fenty-Stewart12016
Deborah B Nixon12010
Barbara D Wright12009

Xikui Chen's Active Locations

  • India
  • Canada
  • Netherlands
  • United States
  • China
  • United Kingdom
  • Taiwan
  • Czech Republic
  • France
  • Germany

Xikui Chen's Year-wise Inspection Count

  • 2009:1 inspections
  • 2010:3 inspections
  • 2011:2 inspections
  • 2014:4 inspections
  • 2016:1 inspections
  • 2017:6 inspections
  • 2018:6 inspections
  • 2019:6 inspections
  • 2020:2 inspections
  • 2023:3 inspections
Last Updated: 2025-05-14 06:11:22