FDA 483 - Trividia Manufacturing Solutions, Inc. - March 06, 2025

Trividia Manufacturing Solutions, Inc. in Lancaster, NH, was inspected and received a Form 483 with four observations. The inspection revealed significant issues including inadequate investigation and timely closure of out-of-specification results, deficient verification of testing methods, and a lack of proper employee training for critical manufacturing tasks. Additionally, the firm's complaint handling procedures were found to be severely lacking, potentially impacting product quality and patient safety.