FDA 483 - Axia Medical Solutions, LLC - July 17, 2025

Axia Medical Solutions, LLC, an own-label drug distributor in Carlsbad, CA, was cited for two significant observations during an FDA inspection. The firm's quality control unit failed to follow written procedures, including issues with product approval, segregation of expired products, and change control, with one issue being a repeat observation. Additionally, the firm lacked adequate temperature monitoring for drug product storage areas, compromising product identity, strength, quality, and purity.