FDA establishment 3013145340, Alvear, Argentina. Part of Terragene S.A.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
FY2018 to FY2027 to date; 1 classified OAI
A hatched bar is a year that is not over, so its count covers only part of the year.
| Ended | Product and area | Citations | Classification |
|---|---|---|---|
| Jun 9, 2023 | Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices | None posted | Official Action Indicated (OAI) |
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