FDA 483 - Vela Operations USA, Inc. - June 01, 2022

Vela Operations USA, Inc. in Salt Lake City, UT, a medical device manufacturer, was cited for multiple quality system deficiencies during an FDA inspection. Key issues include inadequate complaint handling, non-conforming material control, CAPA documentation, software validation, and a complete lack of internal quality audits, management reviews, and device history record procedures since 2018. The findings indicate systemic failures in maintaining a compliant quality management system.