# FDA 483 - UCP Bioscience Inc - November 18, 2024

Source: https://www.globalkeysolutions.net/records/483/ucp-bioscience-inc/63a8d743-a976-4beb-974c-9f0ed8284b71

> FDA 483 for UCP Bioscience Inc on November 18, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: UCP Bioscience Inc
- Inspection Date: 2024-11-18
- Product Type: device
- Office Name: San Francisco District Office
- Summary: UCF Bioscience Inc, a specification developer in Milpitas, CA, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate design history file documentation for a urine cup, failure to appoint a management representative for the quality system, and the absence of written medical device reporting procedures. These issues indicate a lack of robust quality control and regulatory compliance.

## Related Officers

- [Brittany D. Mccracken](https://www.globalkeysolutions.net/people/brittany-d-mccracken/a869ecee-3b7b-4c1a-8c77-7efb1a3d902a)

Company: https://www.globalkeysolutions.net/companies/ucp-bioscience-inc/ddc13d59-57ca-45c1-a2b7-fff3460b5bd4

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