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

inx Medical, LLC was issued an FDA Form 483 following an inspection conducted from October 24-27, 2022. The inspection identified two significant observations related to the company's quality system for its Class II medical device, the Nexus Ligator, indicating potential non-compliance with medical device regulations, specifically 21 CFR 820.The first observation detailed deficiencies in the design history file for the Nexus Ligator. The company failed to provide documentation for required design reviews, an input-output traceability matrix, and design validations, despite these being stipulated in their internal procedures. Additionally, a critical labeling claim of "Latex-free" was introduced without proper documentation of its approval, verification, or inclusion in the design history file.The second major observation concerned inadequacies in the Corrective and Preventive Action (CAPA) system. The FDA noted instances where non-conformance reports, detailing manufacturing issues such as device failures and out-of-specification components, resulted in corrective actions. However, formal CAPA records were not initiated, and essential steps like investigation analysis and verification of effectiveness were not documented or performed, contrary to the company's own CAPA procedures.inx Medical, LLC acknowledged these observations and committed to implementing the necessary corrective actions to ensure compliance with regulatory requirements for medical device manufacturing.