FDA 483 - O3UV, LLC - August 31, 2023

The FDA issued a Form FDA-483 to O3UV, LLC following an inspection conducted from August 23 to August 31, 2023. This document outlines significant deficiencies in the firm's quality management system for medical devices, specifically regarding the EBOO Full Spectrum UV and Champion Full Spectrum UV devices, as well as purchased Class II medical hemodialyzers and Hedy Infusion Pumps.The inspection revealed a widespread absence of established and documented procedures critical for ensuring product quality and regulatory compliance. Key observations included a lack of procedures for corrective and preventive actions, design controls, complaint handling, purchasing controls, and acceptance activities. For instance, the firm lacked defined acceptance criteria and documented test results for the Champion Full Spectrum UV device and had no work instructions for EBOO Full Spectrum UV device assembly or acceptance. Furthermore, O3UV, LLC had not established procedures for device history records, quality audits, or management review.These observations indicate potential non-compliance with the FDA's quality system requirements for medical device manufacturers, as outlined by regulations such as 21 CFR Part 820. While the FDA-483 itself does not mandate specific actions, it serves as notification of objectionable conditions. O3UV, LLC is responsible for thoroughly evaluating these findings, conducting internal audits, and implementing comprehensive corrective actions to address all identified quality system violations to ensure full regulatory adherence.