FDA 483 - Nanova Biomaterials Inc - February 14, 2025

An FDA inspection of Nanova Biomaterials Inc in Columbia, MO, from February 11-14, 2025, identified a significant deficiency in equipment calibration procedures. The firm was found to have used expired fluoride standards to verify the 5% fluoride content of its Sodium Fluoride Varnish, affecting products manufactured and sold since November 2022. This indicates a lapse in quality control and compliance with manufacturing standards.