FDA inspection
Sartorius Stedim Biooutsource Limited: FDA inspection ending Mar 6, 2019
FDA inspection 1086614 · Voluntary Action Indicated (VAI) · Glasgow
Key facts
| Inspection ID | 1086614 |
|---|---|
| Firm | Sartorius Stedim Biooutsource Limited |
| FEI number | 3010165457 |
| Address | Units 1-4, Technology Terrace |
| City | Glasgow |
| Country | United Kingdom |
| Fiscal year | 2019 |
| Inspection end date | Mar 6, 2019 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Human Cellular, Tissue, and Gene Therapies |
| Product type | Biologics |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data