FDA 483 - Clearadvance, LLC - September 04, 2025

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.