FDA 483 - Vevazz LLC - August 04, 2021

Vevazz LLC, a medical device manufacturer in Eaton, CO, was cited for numerous and systemic failures to establish and implement adequate quality system procedures during an FDA inspection. The inspection revealed significant deficiencies across multiple areas, including medical device reporting, complaint handling, design control, supplier management, acceptance activities, equipment control, nonconformance, training, CAPA, device history records, labeling, quality audits, management review, and device distribution. Many of these issues were repeat observations from a previous inspection, indicating persistent non-compliance with regulatory requirements.