FDA 483 - inx Medical, LLC - October 27, 2022

An FDA inspection of inx Medical, LLC, a manufacturer of the Nexus Ligator medical device, revealed significant deficiencies in their quality system. The firm failed to maintain an adequate design history file, lacking documentation for design reviews, verification, validation, and labeling changes. Additionally, the company's corrective and preventive action procedures were found to be inadequate, with instances where CAPAs were not initiated for non-conformances and effectiveness checks were not performed.