FDA 483 - OXITONE MEDICAL LTD - June 15, 2023

An FDA inspection of OXITONE MEDICAL LTD conducted from June 12-15, 2023, uncovered significant deficiencies in the medical device manufacturer's quality management system. The observations primarily highlighted non-compliance with regulatory frameworks including the Quality System Regulation (21 CFR Part 820) and Unique Device Identification (UDI) requirements (21 CFR Part 801 Subpart B, 21 CFR Part 830).

Key issues identified included inadequate procedures for Medical Device Reporting (MDR), specifically concerning event evaluation, definition of key terms, and timely reporting. The firm failed to submit required UDI information for its Oxitone 1000M device to the Global UDI Database, and the device's labeling lacked a machine-readable UDI. Corrective and Preventive Action (CAPA) procedures were found to be insufficient, lacking defined quality data analysis and records to address increasing failure rates in subassemblies. Deficiencies also extended to design input procedures, which did not adequately define requirements or mechanisms to resolve conflicting design specifications. Furthermore, critical records, such as design validation protocols and design review documents, were not readily available. The acceptance status of product components was not consistently identified, and Device History Records were incomplete, missing crucial manufacturing and testing details.

OXITONE MEDICAL LTD is required to implement comprehensive corrective actions to resolve these observations, ensuring full compliance with FDA regulations governing medical device manufacturing and quality systems.