FDA 483 - Gottfried Medical, Inc. - July 31, 2025

Gottfried Medical, Inc. in Toledo, OH, a medical device manufacturer, was cited with three observations on a Form FDA 483. The inspection revealed deficiencies in controlling non-conforming products, inadequate procedures for supplier and raw material controls, and a failure to include Unique Device Identifiers (UDI) on medical device labels. These issues indicate significant concerns with the firm's quality system and compliance with device labeling regulations.