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Welch Allyn Inc (Baxter affiliate), Milwaukee, WI – FDA Inspections

Inspection records and compliance data for Welch Allyn Inc (Baxter affiliate) in Milwaukee, Wisconsin. 4 FDA inspections on record, 1 Form 483, last inspected July 15, 2022.

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Company Profile

This profile covers Welch Allyn Inc (Baxter affiliate) based in Milwaukee, Wisconsin, United States.

FDA Inspection History

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

First inspected May 10, 2011. Last inspected July 15, 2022.

Most cited issue areas

  • Documentation2 inspections
  • Investigation of device failures2 inspections
  • Lack of or inadequate complaint procedures2 inspections

FDA inspections (4)

DateResultFDA center(s)Insp. #
July 15, 2022VAIMedical Devices & Rad Health · Postmarket Assurance: Devices1174547
April 7, 2017VAIMedical Devices & Rad Health · Postmarket Assurance: Devices1015603
September 18, 2013VAIMedical Devices & Rad Health · Compliance: Devices851694
May 10, 2011VAIMedical Devices & Rad Health · Postmarket Assurance: Devices723748
FDA documents

Form 483s (1)

  • Form 483s · July 15, 2022
People (1)
Jesse A. Vazquez
Person
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Freudenberg Medical, LLC
Med Labs Inc
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Company Information

Name

Welch Allyn Inc (Baxter affiliate)

FEI Number

2183461

Address

7865 N 86th St, Milwaukee, Wisconsin 53224, United States

Country

United States

ID: 718f095d-9e77-47ef-bd93-e368b57a050d

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