FDA 483 - Veridian Healthcare - November 28, 2018

Veridian Healthcare, LLC, an own label distributor in Gurnee, IL, was cited for multiple deficiencies related to quality control, complaint handling, adverse event reporting, and recall procedures. The inspection revealed a lack of authority for the quality unit, failure to follow written procedures, inadequate complaint investigations, and unreported adverse drug events. Additionally, the firm lacked a written recall procedure for drug products.