FDA 483 - Innova Vascular Inc - January 12, 2026

Innova Vascular Inc., a medical device manufacturer in Irvine, CA, was cited for significant quality system deficiencies during an FDA inspection. The firm demonstrated inadequate procedures for finished device acceptance, including failures in tensile testing, insufficient sample sizes, and improper pooling of different product lots. Additionally, deficiencies were noted in complaint handling, where devices were not retrieved for evaluation and critical information like lot numbers were not obtained, and the firm's risk analysis was found to be inadequate, failing to properly assess the severity of vessel trauma and omitting critical failure modes from its FMEAs.