FDA 483 - Synovo Production, Inc. - October 26, 2022

Synovo Production, Inc. in Fullerton, CA, a manufacturer of hip replacement systems, received a Form FDA 483 with seven observations following an inspection from October 11-26, 2022. The inspection revealed significant deficiencies in quality system procedures, including inadequate process validation, design change controls, CAPA effectiveness verification, supplier qualification documentation, management reviews, internal audits, and personnel training records. These issues indicate a systemic breakdown in maintaining a compliant quality management system for medical devices.