FDA 483 - Vero Biotech Inc - October 24, 2019

An FDA inspection of Vero Biotech, LLC in Atlanta, GA, revealed two significant observations. The firm was cited for inadequate written procedures for its quality control unit, specifically regarding rework activities and limits. Additionally, deviations from production and process control procedures were not justified, as evidenced by an equipment IOQ failure that was deemed passing without a root cause analysis.