FDA 483 - Avacen Inc. - July 20, 2021

Avacen Inc. received a Form FDA 483 with 10 observations during an inspection from July 12-20, 2021, in Carlsbad, CA. The inspection revealed significant deficiencies across its quality system, including inadequate procedures for complaint handling, corrective and preventive actions, acceptance activities, supplier control, device master records, device history records, servicing instructions, organizational structure, quality audits, and personnel training. These issues indicate a systemic failure to maintain a compliant quality management system for medical device manufacturing.