Sartorius Stedim Biooutsource Limited
Sartorius Stedim Biooutsource Limited has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Sep 5, 2025 · NAI
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 5 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 5, 2025 | Glasgow, United Kingdom | Drugs | No Action Indicated (NAI) | 3010165457 |
| Dec 11, 2019 | Glasgow, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3010165457 |
| Mar 6, 2019 | Glasgow, United Kingdom | Biologics | Voluntary Action Indicated (VAI) | 3010165457 |
| Sep 13, 2017 | Glasgow, United Kingdom | Biologics | No Action Indicated (NAI) | 3010165457 |
| Jan 26, 2016 | Glasgow, United Kingdom | Drugs | No Action Indicated (NAI) | 3010165457 |
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3010165457 | Glasgow, United Kingdom | 5 | Sep 5, 2025 |