FDA establishment 3000205943, Southlake, Texas, United States. Part of Electro Medical Systems SA's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
FY2018 to FY2027 to date; 0 classified OAI
A hatched bar is a year that is not over, so its count covers only part of the year.
Inspections citing each reference
| Ended | Product and area | Citations | Classification |
|---|---|---|---|
| Oct 21, 2025 | Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices | 3 cited references
| No Action Indicated (NAI) |
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. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. 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, warning letters and enforcement reports
Southlake, Texas, United States. Part of