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Wuxi Biologics Co Ltd, Wuxi, China – FDA Inspections

Inspection records and compliance data for Wuxi Biologics Co Ltd in Wuxi. 6 FDA inspections on record, 5 Form 483s, last inspected July 03, 2026.

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Company Profile

This profile covers Wuxi Biologics Co Ltd based in Wuxi, China.

FDA Inspection History

FDA inspections
6
OAI
0
VAI
2
NAI
0
Unclassified
4
Form 483s
5
Warning letters
0

First inspected August 2, 2017. Last inspected July 3, 2026.

FDA inspections (6)

DateResultFDA center(s)Insp. #
July 3, 2026Not classifiedHuman Drugs1324932
June 4, 2024Not classifiedHuman Drugs1274331
May 9, 2023Not classifiedHuman Drugs1219694
April 2, 2021VAIHuman Drugs · Drug Quality Assurance1137612
April 16, 2019VAIHuman Drugs · Drug Quality Assurance1086695
August 2, 2017Not classifiedHuman Drugs1028829
FDA documents

Form 483s (4)

  • Form 483s · June 4, 2024
  • Form 483s · May 9, 2023
  • Form 483s · April 2, 2021
  • Form 483s · April 16, 2019

EIRs (2)

  • EIRs · April 2, 2021
  • EIRs · April 8, 2019
Other regulators (1)
  • UK MHRA · 1 inspection · last August 12, 2025
People (6)
Christopher T. Middendorf
Person
Zhisheng Chen
Person
Ramesh Potla
Person
Mekonnen Lemma Dechassa
Person
Kevin A. Gonzalez
Person
Jonathan W. Chapman
Person
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Company Information

Name

Wuxi Biologics Co Ltd

FEI Number

3010606982

Address

108 Meiliang Road, Binhu, Wuxi, China

Country

China

ID: 67a28116-624d-42f6-adae-18cf80094862

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