FDA 483 - DeGen Medical Inc. - September 12, 2024

DeGen Medical Inc. in Florence, SC, a specification developer, was cited for deficiencies in its design validation processes for a Class II medical device. The inspection revealed that the firm failed to ensure the device conformed to defined user needs and intended uses, and that validation activities were not conducted under actual or adequately simulated use conditions. These observations highlight significant issues with the firm's design controls.