FDA 483 - RUA Medical (Irvine) - October 18, 2018

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from October 15 to October 18, 2018, RUA Medical (Irvine) received a Form FDA 483. This document outlined observations made by the FDA investigator regarding the firm's operations. The primary observation identified was that procedures for quality audits had not been adequately established. Specifically, the FDA noted deficiencies in the methods used to determine the completeness and accuracy of records, as well as in the record review procedures concerning the challenge and escalation of sample sizes and the time frames covered by these reviews. These observations suggest potential non-compliance with the regulatory framework governing quality systems for medical device manufacturers. A Form FDA 483 is issued when investigators observe conditions that may be violations of the Food, Drug, and Cosmetic Act and related regulations. It is not a final determination of compliance but highlights areas requiring attention. RUA Medical (Irvine) is required to thoroughly review these observations and initiate appropriate corrective actions to address the identified inadequacies in their quality audit system. The firm has the opportunity to discuss any objections or present a detailed plan for corrective and preventive actions to the FDA, demonstrating their commitment to maintaining robust quality systems as mandated by regulatory requirements.