FDA 483 - Navinta, LLC - June 29, 2023

Navinta, LLC, a manufacturer in Ewing, NJ, was inspected by the FDA from June 20-29, 2023. The inspection revealed significant deficiencies across its quality system, including inadequate procedures for supplier evaluation, design control, quality audits, and corrective and preventive actions. Furthermore, critical manufacturing and packing processes for device components were found to be inadequately validated, leading to high reject rates without documented reasons.