483
Welch Allyn IncFDA 483 - Welch Allyn Inc - January 09, 2026
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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.
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ID · 88d24a8a-40f4-4296-ac85-8653effc20e4