FDA 483 - TRIUMPH PHARMACEUTICALS INC - April 29, 2025

Triumph Pharmaceuticals Inc., a specification developer of the SmartMouth DryMouth Oral Rinse medical device, underwent an FDA inspection from April 28-29, 2025. The inspection resulted in two significant observations regarding compliance with medical device regulations.

Firstly, the company failed to ensure that its medical device labels included a Unique Device Identifier (UDI), a requirement under 21 CFR 801 Subpart B and 21 CFR 830. Annually, a significant number of units of the oral rinse were distributed without this essential labeling.

Secondly, the company's organizational structure and quality system were found to be inadequate for designing and producing devices in accordance with 21 CFR 820, the Quality System Regulation. Specifically, Triumph Pharmaceuticals had not developed or implemented critical procedures covering design controls, quality system audits, management reviews, purchasing controls, and personnel training, despite engaging a contract manufacturer for production.

These observations highlight the need for Triumph Pharmaceuticals to enhance its labeling practices and establish a robust quality management system. The company indicated a commitment to correct both identified issues. This FDA 483 document serves as an official communication of these findings, requiring the firm to take appropriate corrective actions to ensure ongoing compliance.