FDA 483 - Navinta, LLC - June 29, 2023
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
- Person
ID · 2d8fac09-1d22-43ef-972e-36ca1184987c