483
DeGen Medical Inc.DeGen Medical Inc. – FDA 483, Sep 12, 2024
Record Details
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.
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- Atlanta District Office
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ID · 47f2de1a-a7f8-412c-81b6-a88d079e5281
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