FDA establishment 3003952420, Guilford, Connecticut, United States. Part of Bio-Med Devices'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 |
|---|---|---|---|
| Dec 20, 2024 | Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices | 1 cited reference
| No Action Indicated (NAI) |
| Mar 31, 2022 | Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices | 2 cited references
| No Action Indicated (NAI) |
| Aug 18, 2016 | Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices | 1 cited reference
| Voluntary Action Indicated (VAI) |
| May 26, 2011 | 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