Mobia Medical Inc

FDA establishment 3012309950, Lakeway, Texas, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.

Inspections: 2
Official action indicated: 0
Last inspection ended: Mar 19, 2026
Warning letters: 0
Import refusals since 2024: 1

Inspections by Fiscal Year

FY2018 to FY2027 to date; 0 classified OAI

02019

02021

02023

02025

02027

Most Cited at This Site

Inspections citing each reference

21 CFR 803.50(a)(1): Report of Death or Serious Injury1

Inspections

2 inspections, newest first

Ended	Product and area	Citations	Classification
Mar 19, 2026	Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices	1 cited reference 21 CFR 803.50(a)(1). Report of Death or Serious Injury An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.	Voluntary Action Indicated (VAI)
May 19, 2022	Devices · Compliance: DevicesDevices · Project Evaluation: Devices	None posted	No Action Indicated (NAI)

Import Refusals

1 refused shipment lines since 2024, grouped by product and charges

Product	Charges	Latest
STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR STROKE REHABILITATIONDevices · 89QPY	NO PMA	Sep 2, 2025

Identifiers

FEI number: 3012309950
FDA firm profile: Data Dashboard

An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard and warning letters