# FDA 483 - Welch Allyn Inc - January 09, 2026

Source: https://www.globalkeysolutions.net/records/483/welch-allyn-inc/88d24a8a-40f4-4296-ac85-8653effc20e4

> FDA 483 for Welch Allyn Inc on January 09, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Welch Allyn Inc
- Inspection Date: 2026-01-09
- Product Type: device
- Office Name: New York District Office
- Summary: An FDA inspection of Welch Allyn, Inc. in Skaneateles Falls, NY, a medical device manufacturer, revealed an inadequacy in their corrective and preventive action (CAPA) procedures. Specifically, a CAPA related to a product recall for PocketScope batteries did not include an adequate investigation into the root cause of the issue. This indicates a significant lapse in their quality system implementation.

## Related Documents

- [483 - 2023-08-17](https://www.globalkeysolutions.net/records/483/welch-allyn-inc/24124108-6533-4fbf-a92a-2245f3a3628d)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/wendy-m-stone/715b04f5-3949-4ca6-9bda-26ff611e9354)
- [Matthew D. Schnittker](https://www.globalkeysolutions.net/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

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

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d