FDA 483 - Welch Allyn Inc - January 09, 2026

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.