FDA 483 - NeuroVention, LLC - May 31, 2023

An FDA inspection of NeuroVention, LLC in Daytona Beach, FL, a manufacturer of the Neurovention Cranial Fixation System (Class II), revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, lacking requirements for data analysis and complete CAPA documentation. Additionally, procedures for internal quality audits were not properly established or followed, with audits not being performed as required and conducted by individuals with direct responsibility for the audited matters.