# FDA 483 - Clearadvance, LLC - September 04, 2025

Source: https://www.globalkeysolutions.net/records/483/clearadvance-llc/849e424e-b47c-4612-b297-b2c7279746ad

> FDA 483 for Clearadvance, LLC on September 04, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Clearadvance, LLC
- Inspection Date: 2025-09-04
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: Clearadvance, LLC, a medical device manufacturer in Irvine, CA, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to conduct internal quality audits or document management reviews since its device's release. Additionally, inadequate document control procedures were observed, and the firm's medical device lacked a unique device identifier (UDI) on its labels, with no UDI data submitted to the FDA's GUDID.

## Related Officers

- [Tyler J. Chia](https://www.globalkeysolutions.net/people/tyler-j-chia/0f17c8f0-f7bc-4e5d-bbfa-a8bc7aa5dd66)
- [Investigator](https://www.globalkeysolutions.net/people/alexandria-l-capuano/f76c710a-613f-42b2-8958-1292fa329112)

Company: https://www.globalkeysolutions.net/companies/clearadvance-llc/769ed9c5-1e23-48cb-b055-7cd51384cdfa

Office: https://www.globalkeysolutions.net/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b