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Bradshaw Medical, Inc., Kenosha, WI – FDA Inspections

Inspection records and compliance data for Bradshaw Medical, Inc. in Kenosha, Wisconsin. 4 FDA inspections on record, 2 Form 483s, last inspected September 12, 2025.

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Company Profile

This profile covers Bradshaw Medical, Inc. based in Kenosha, Wisconsin, United States.

FDA Inspection History

FDA inspections
4
OAI
0
VAI
3
NAI
1
Form 483s
2
Warning letters
0

First inspected April 11, 2016. Last inspected September 12, 2025.

Most cited issue areas

  • Lack of or inadequate procedures3 inspections
  • Lack of or inadequate complaint procedures2 inspections
  • Nonconforming product, Lack of or inadequate procedures2 inspections

FDA inspections (4)

DateResultFDA center(s)Insp. #
September 12, 2025NAIMedical Devices & Rad Health · Postmarket Assurance: Medical Devices1281560
February 28, 2022VAIMedical Devices & Rad Health · Postmarket Assurance: Devices1163303
August 15, 2017VAIMedical Devices & Rad Health · Compliance: Devices1021772
April 11, 2016VAIMedical Devices & Rad Health · Postmarket Assurance: Devices982611
FDA documents

Form 483s (3)

  • Form 483s · September 12, 2025
  • Form 483s · February 28, 2022
  • Form 483s · August 15, 2017
People (4)
Michelle J. Glembin
Person
Nicholas T. Domer
Person
Nicholas Z. Lu
Person
Shuana H. Xiong
Person
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Company Information

Name

Bradshaw Medical, Inc.

FEI Number

3006846753

Address

10325 58th Pl, Kenosha, Wisconsin 53144, United States

Country

United States

ID: 9a789895-c4a2-4b8d-9ae9-f2e2457ccb88

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