FDA 483 - Micro-X Ltd. - May 23, 2024

From May 20 to May 23, 2024, the U.S. Food and Drug Administration (FDA) conducted an inspection of Micro-X Ltd. at its manufacturing facility in South Australia. The resulting Form 483 outlines several significant quality system violations related to the firm"s Micro-X Rover Mobile X-ray Systems. A major issue identified was the failure to report multiple field corrections and service bulletins to the FDA. These corrections addressed critical risks, including firmware errors during radiation exposure, hardware modifications to prevent accidental activation, and system failures caused by extreme humidity. Additionally, the FDA found that the company’s design change controls were inadequate; the firm frequently utilized manufacturing deviation records rather than formal design change protocols, leading to a lack of proper validation for product modifications. The inspector also noted that the manufacturing process for the RV71 model, distributed in the United States, had not been validated. Furthermore, the firm"s procedures for Corrective and Preventive Action (CAPA) and complaint handling were deemed insufficient, particularly regarding the evaluation of malfunctions for Medical Device Reporting (MDR). These observations were issued under the Federal Food, Drug, and Cosmetic (FD&C) Act. Micro-X Ltd. is expected to respond to these findings with a detailed plan for corrective actions and is responsible for performing internal audits to ensure future compliance with all quality system requirements.