FDA 483 - Trigon America LLC - February 13, 2019

Trigon International LLC, a medical device manufacturer in Aurora, IL, was inspected by the FDA from February 5-13, 2019. The inspection revealed significant deficiencies in their quality system, including inadequate procedures for finished device acceptance, unvalidated manufacturing processes, and failures in their corrective and preventive action (CAPA) system. Repeat observations were noted for CAPA file maintenance and complaint handling, indicating persistent quality control issues.