FDA 483 - Novum Medical Products of NY, LLC - December 05, 2023

During an inspection conducted by the U.S. Food and Drug Administration (FDA) on December 4-5, 2023, Novum Medical Products of NY, LLC, a medical device manufacturer, received a Form FDA 483. The inspection revealed deficiencies in the company's quality system, specifically concerning corrective and preventive action (CAPA) procedures. The primary observation noted that Novum Medical Products of NY, LLC had not adequately established procedures for corrective and preventive actions. The FDA investigator found that in 4 out of 13 reviewed CAPAs, there was insufficient verification or validation to confirm the effectiveness of the corrective actions taken. Furthermore, one CAPA failed to address all identified issues. This particular observation is significant as it was a repeat finding from a previous inspection, indicating a persistent issue. Issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, the Form FDA 483 highlights conditions that require attention. Novum Medical Products of NY, LLC is now responsible for conducting thorough self-audits and implementing robust corrective actions to address these quality system violations and ensure compliance with regulatory standards for medical device manufacturing. The company acknowledged the observation and promised to correct the identified deficiencies.