Facility

VERO BIOTECH INC.

3 recall(s) on record — most severe on record: Class I.

Key facts

3recalls · worst Class I

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3012160128
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	208 N Main St Livingston, TN, US 38570
Registration status	Active · expires 2026
Parent company	Vero Biotech Inc. (owner-operator 10095885)
Brand names	NOxBOXi System Patient Kits

Activity by year

Recalls (3)

Devices registered here (1)

Apparatus, Nitric Oxide Delivery
Product code MRN (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5165

Recalls & enforcement

Class IIOngoing2023-11-17
Cassette did not meet an 1n-process flow criterion.
Class ICompleted2021-09-09
Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).
Class ITerminated2021-05-19
Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field.

All facilities operated by Vero Biotech Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “VERO BIOTECH INC. (FEI 3012160128) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012160128-vero-biotech-inc/

Not open yet

Alerts for VERO BIOTECH INC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.