FDA 483 - National Medical Products Inc - May 30, 2024

During an inspection conducted from May 28 to May 30, 2024, the Food and Drug Administration (FDA) issued a Form 483 to National Medical Products Inc., a medical device manufacturer located in Irvine, CA. The primary observation concerned deficiencies in the firm's procedures for corrective and preventive actions (CAPA). Specifically, the company's CAPA procedure, SOP 2-1003, was found to lack a crucial requirement: verifying or validating the effectiveness of implemented corrective actions to ensure they resolve the identified issues and do not negatively affect finished medical devices. An instance was cited where CAPA 17, initiated to address high particulate counts in a gowning area, was closed without documented verification that the actions taken were effective long-term or had no adverse impact on the products. This indicates a gap in the firm's quality system, which is governed by the Federal Food, Drug, and Cosmetic Act. National Medical Products Inc. is required to promptly address these observations by revising its CAPA procedures to include robust effectiveness verification and ensuring compliance with all applicable quality system regulations to prevent recurrence and maintain product quality and safety.