FDA 483 - SAFC Carlsbad Inc. - September 12, 2019

An FDA inspection of SAFC Carlsbad, Inc. in Carlsbad, CA, a manufacturer of viral vectors, identified eight observations related to deficiencies in environmental monitoring, label control, supplier qualification, equipment qualification, raw material inspection, consumable equipment qualification, environmental monitoring incubation conditions, and functional training. The findings indicate several areas where the firm's quality systems and controls require improvement to ensure product quality and compliance.