FDA establishment 3001763079, San Jose, California, United States. 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
| Oct 23, 2025 | Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices | 3 cited references
| Voluntary Action Indicated (VAI) |
| Nov 16, 2022 | Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices | None posted | No Action Indicated (NAI) |
| Sep 4, 2019 | Devices · Compliance: Devices | None posted | 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
San Jose, California, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.