Vero Biotech, LLC

FDA Regulatory Profile

Vero Biotech, LLC appears in FDA public data with 3 recalls — including 2 Class I (most serious) —, 0 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0564-2024, Class II) was initiated on November 17, 2023.

Summary

Total Recalls
3 (2 Class I)
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0564-2024Class IIVERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates aNovember 17, 2023
Z-2587-2021Class IGENOSYL DS (Delivery System) console, for use as a vasodilator.September 9, 2021
Z-1863-2021Class IGENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860May 19, 2021