# FDA 483 - ENABLE BIOSCIENCES - October 17, 2024

Source: https://www.globalkeysolutions.net/records/483/enable-biosciences/5a13886a-cff9-414e-9828-4d1741db85f0

> FDA 483 for ENABLE BIOSCIENCES on October 17, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ENABLE BIOSCIENCES
- Inspection Date: 2024-10-17
- Product Type: device
- Office Name: San Francisco District Office
- Summary: 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.

## Related Officers

- [Nga T. Ho](https://www.globalkeysolutions.net/people/nga-t-ho/7c7d96a2-9b2c-4966-8dc2-ee20ca024be1)

Company: https://www.globalkeysolutions.net/companies/enable-biosciences/29e27931-b3d3-4796-9bcc-ba0e13c2bdaa

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df