FDA 483 - Vevazz LLC - June 20, 2019

Vevazz LLC, a medical device manufacturer in Eaton, CO, was inspected by the FDA from June 3-20, 2019. The inspection revealed significant deficiencies across its quality management system, with 15 observations citing a lack of established or adequately implemented procedures for critical areas. These issues indicate a systemic failure to comply with medical device quality system regulations.