FDA 483 - VVF Kansas Services LLC - May 18, 2021

VVF Kansas Services LLC, an OTC manufacturer, was inspected by the FDA on May 18-19, 2021. The inspection revealed a significant issue with computer system controls, specifically regarding the lack of backups and password protection for HPLC and FTIR systems. This deficiency could compromise data integrity and prevent proper record-keeping, indicating a moderate severity issue related to quality control.