FDA 483 - Rinovum Subsidiary 2 LLC - September 15, 2023

An FDA inspection of Rinovum Subsidiary 2 LLC in Monroeville, PA, identified a significant deficiency in the firm's complaint handling system. The company failed to adequately review, evaluate, and investigate customer complaints related to potential device, labeling, and packaging failures. This issue was noted as a repeat observation from a previous inspection, highlighting a persistent non-compliance.