# FDA 483 - Welch Allyn Inc - August 17, 2023

Source: https://www.keypedia.com/records/483/welch-allyn-inc/24124108-6533-4fbf-a92a-2245f3a3628d

> FDA 483 for Welch Allyn Inc on August 17, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Welch Allyn Inc
- Inspection Date: 2023-08-17
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Welch Allyn Inc, a medical device manufacturer in Skaneateles Falls, NY, received one observation during an FDA inspection. The observation cited inadequately established procedures for corrective and preventive actions (CAPA). Specifically, one CAPA related to a recall lacked adequate verification of effectiveness for all corrective actions taken.

## Related Documents

- [483 - 2026-01-09](https://www.keypedia.com/records/483/welch-allyn-inc/88d24a8a-40f4-4296-ac85-8653effc20e4)

## Related Officers

- [Matthew D. Schnittker](https://www.keypedia.com/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.keypedia.com/companies/welch-allyn-inc/b4a5b43c-1013-407c-a959-d13e68e06367

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961