ENABLE BIOSCIENCESOctober 17, 2024

FDA 483 - ENABLE BIOSCIENCES - October 17, 2024

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ENABLE BIOSCIENCES in South San Francisco, CA, was inspected by the FDA from October 15-17, 2024. The inspection revealed that the firm has not established procedures for receiving, reviewing, and evaluating complaints for its Class II diagnostic product, a test for type I diabetes mellitus, which has been distributed since August 2022. This indicates a significant lapse in quality system controls for a medical device.

Company: ENABLE BIOSCIENCES
Inspection Date: October 17, 2024
Product Type: Device
Office: San Francisco District Office
Person: Nga T. Ho

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ID · 5a13886a-cff9-414e-9828-4d1741db85f0