FDA 483 - Vanton Research Laboratory, LLC - July 01, 2019

Vanton Research Laboratory, LLC, a control testing laboratory in Concord, CA, was cited for failing to perform routine calibration of equipment according to a written program. Specifically, the firm did not calibrate or conduct temperature mapping studies for its stability chambers under loaded conditions, and lacked proper written procedures for these activities. This indicates a significant lapse in quality control for critical equipment.