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FDA Inspection
•Welch Allyn Inc (Baxter affiliate)•July 15, 2022

Welch Allyn Inc (Baxter affiliate) – FDA Inspection, Jul 15, 2022

Record Details

This FDA Inspection record concerns Welch Allyn Inc (Baxter affiliate), with an inspection on July 15, 2022, issued by the Center for Devices and Radiological Health, covering devices.

Company
Welch Allyn Inc (Baxter affiliate)
Inspection Date
July 15, 2022
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 773a3fc5-d6f3-4664-83d6-77c94dd5cf09

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1174547
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices

FDA Citations

1
  1. 21 CFR 820.100(b)Documentation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Welch Allyn Inc (Baxter affiliate)

3
DateClassificationOfficeProject area
April 7, 2017VAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
September 18, 2013VAICenter for Devices and Radiological HealthCompliance: Devices
May 10, 2011VAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
Other documents for Welch Allyn Inc (Baxter affiliate)
  • FDA Inspection 1015603 - 2017-04-07
  • FDA Inspection 851694 - 2013-09-18
  • FDA Inspection 723748 - 2011-05-10

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