FDA 483 - UIH Technologies LLC - August 20, 2025

An FDA inspection conducted from August 6-20, 2025, at UIH Technologies LLC, a medical device contract manufacturer in Houston, TX, revealed significant deficiencies in their quality system. The firm received a Form FDA 483, highlighting three main observations. Firstly, medical device labels lacked a complete Unique Device Identifier (UDI) in both plain-text and automatic identification and data capture technology, specifically omitting the manufacturing date from the UDI-PI. Secondly, the company's procedures for handling customer complaints were found to be inadequate. Complaint files were incomplete, frequently missing crucial details such as the device's UDI, comprehensive investigation results, formal responses to customers, and evidence of complaint closure. Examples cited included issues with device cooling, a component being sucked into moving parts, and a defective power supply connector. Finally, finished device acceptance procedures were not adequately established. The acceptance test, a critical part of final inspection, lacked detailed requirements and methods in its test instructions and reports. Furthermore, the completed acceptance test printouts were signed only by the user, without a required review and signature by another qualified Quality personnel. These observations indicate potential non-compliance with the Federal Food, Drug, and Cosmetic Act concerning medical device quality system regulations. UIH Technologies LLC has indicated a commitment to correct all identified issues. The firm is expected to submit a detailed written response outlining its corrective and preventive actions to address these findings.