FDA establishment 3009399851, Roseville, Michigan, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
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 28, 2026 | Biologics · Blood and Blood Products | None posted | No Action Indicated (NAI) |
| Feb 17, 2023 | Biologics · Blood and Blood ProductsBiologics · Vaccines and Allergenic Products | None posted | No Action Indicated (NAI) |
| Jan 10, 2018 | Biologics · Blood and Blood Products | 1 cited reference
| Voluntary Action Indicated (VAI) |
| Feb 1, 2016 | Biologics · Blood and Blood Products | None posted | No Action Indicated (NAI) |
| Recalled product | Class | Classified |
|---|---|---|
| Source PlasmaBiologic · B-0852-2019 | Class III | Jun 10, 2019 |
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
Roseville, Michigan, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.