FDA 483 - Synovo Production, Inc. - October 02, 2023

Synovo Production, Inc. in Fullerton, CA, was inspected regarding its manufacturing of medical devices, specifically hip replacement systems. The inspection revealed significant deficiencies in quality system documentation, including failures in process validation, design history file establishment, corrective and preventive actions, supplier qualification, and personnel training. Many of these observations were repeats from a previous inspection, indicating a persistent lack of compliance.