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

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.