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WuXi AppTec, Inc., Saint Paul, MN – FDA Inspections

Inspection records and compliance data for WuXi AppTec, Inc. in Saint Paul, Minnesota. 10 FDA inspections on record (1 OAI), 1 Form 483, last inspected August 21, 2025.

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Company Profile

This profile covers WuXi AppTec, Inc. based in Saint Paul, Minnesota, United States.

FDA Inspection History

FDA inspections
10
OAI
1
VAI
1
NAI
7
Unclassified
1
Form 483s
1
Warning letters
0

First inspected June 11, 2009. Last inspected August 21, 2025.

Most cited issue areas

  • Animal care: analysis of feed and water1 inspection
  • Archives: data, documentation, specimens1 inspection
  • Archives: individual responsible1 inspection

FDA inspections (10)

DateResultFDA center(s)Insp. #
August 21, 2025Not classifiedHuman Drugs1284572
September 10, 2019OAIMedical Devices & Rad Health · Project Evaluation: Devices1101548
March 30, 2018NAIHuman Drugs · Drug Quality Assurance1052461
March 7, 2017NAIBiologics · Human Cellular, Tissue, and Gene Therapies1002870
August 26, 2015NAIBiologics · Human Cellular, Tissue, and Gene Therapies946210
March 27, 2015NAIHuman Drugs · Drug Quality Assurance920003
September 7, 2012NAIBiologics, Medical Devices & Rad Health · Human Cellular, Tissue, and Gene Therapies797881
May 17, 2012NAIHuman Drugs · Drug Quality Assurance783809
September 7, 2010NAIBiologics · Human Cellular, Tissue, and Gene Therapies680463
June 11, 2009VAIHuman Drugs · Drug Quality Assurance588318
FDA documents

Form 483s (3)

  • Form 483s · September 7, 2022
  • Form 483s · September 10, 2019
  • Form 483s · April 13, 2015

EIRs (1)

  • EIRs · September 7, 2022
Other regulators (1)
  • UK MHRA · 4 inspections · last March 2, 2017
People (3)
Gayle S. Lawson
Person
Nicole C. Victoria
Person
Sharon L. Matson
Person
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Geneva Laboratories, Inc
Company Information

Name

WuXi AppTec, Inc.

FEI Number

3002199759

Address

2540 Executive Dr, Saint Paul, Minnesota 55120, United States

Country

United States

ID: 5a415856-23a1-4f69-a085-cda0d9ae9ca3

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Contact
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Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
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🇪🇺+48 532-447-507
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