Axia Medical Solutions, LLC – FDA 483, Jul 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.
ID · 35b70694-e83b-4c5b-ab18-9593b8cc98ec
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.