FDA 483 - Genlabs Corporation - December 09, 2021

Genlabs Corporation, a pharmaceutical manufacturer in Chino, CA, was inspected by the FDA and received a Form 483 with nine observations. The inspection revealed significant deficiencies across quality control, laboratory controls, facilities, equipment, and packaging/labeling systems, including a lack of written procedures, inadequate validation, and issues with product release and equipment maintenance. Several observations were repeats from a previous inspection, indicating persistent non-compliance.