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

An FDA inspection conducted on December 4-5, 2023, at Novum Medical Products of NY, LLC, a medical device manufacturer in Amherst, NY, identified a significant deficiency concerning their quality system. The primary observation, issued to President Joseph P. Manzella, highlighted that the company's procedures for corrective and preventive action (CAPA) were not adequately established, a repeat observation from a previous inspection. Specifically, the FDA investigator found that in 4 out of 13 CAPAs reviewed, there was insufficient verification or validation to ensure the effectiveness of corrective actions taken. Furthermore, one of the 13 CAPAs failed to include corrective actions that addressed all identified issues within that specific case. These findings indicate a systemic weakness in Novum Medical Products' ability to effectively identify, correct, and prevent recurrence of quality-related problems, as mandated by regulatory requirements for medical device manufacturers. The firm has acknowledged the observation and promised to implement corrections. As an FDA 483 document, these observations are not a final determination of compliance, but the company is obligated to conduct internal audits and rectify all identified and underlying quality system violations to ensure product safety and effectiveness.