# FDA 483 - Welch Allyn Inc (Baxter affiliate) - July 15, 2022

Source: https://www.keypedia.com/records/483/welch-allyn-inc-baxter-affiliate/e31df724-65c4-4d34-87d0-da0a35294a8c

> FDA 483 for Welch Allyn Inc (Baxter affiliate) on July 15, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Welch Allyn Inc (Baxter affiliate)
- Inspection Date: 2022-07-15
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Welch Allyn Inc. (a Baxter affiliate) in Milwaukee, WI, identified significant deficiencies in their corrective and preventive action (CAPA) documentation. The firm failed to adequately address known cybersecurity vulnerabilities in several medical devices and did not properly document corrective actions for issues related to incorrect serial number entry and duplicate serial numbers. These findings highlight a lack of robust quality system processes for managing product-related issues.

## Related Officers

- [Medical Device Specialist](https://www.keypedia.com/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

Company: https://www.keypedia.com/companies/welch-allyn-inc-baxter-affiliate/718f095d-9e77-47ef-bd93-e368b57a050d

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669