FDA 483 - Carroll-Baccari Inc - August 05, 2025

The FDA inspection of Mavidon Medical Products in Flat Rock, NC, revealed widespread deficiencies across its quality management system, indicating a lack of adequate controls for medical device manufacturing. Significant issues include ineffective corrective and preventive actions, inadequate control of non-conforming products, and insufficient process controls. The firm also failed to establish proper procedures for complaint handling, equipment calibration, supplier management, product identification, software validation, MDR reporting, personnel training, and document control, posing risks to product quality and patient safety.