Patheon Biologics LLC
Patheon Biologics LLC has 0 FDA recalls, 12 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Nov 20, 2024 · VAI
Newer recall under related name Life Technologies Holdings: Aug 14, 2026, Z-0211-2027.
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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 | 12 | Nov 10, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Related names
| Name | Recalls | 510(k) | Inspections | Compliance | Most recent recall |
|---|---|---|---|---|---|
| Life Technologies Holdings | 5 | 0 | 5 | 0 | Aug 14, 2026 (Z-0211-2027) |
| Life Technologies Corporation | 13 | 8 | 16 | 0 | Feb 7, 2024 (Z-1426-2024) |
| Thermo Fisher Scientific | 1 | 65 | 3 | 0 | Feb 1, 2021 (Z-1202-2021) |
| Life Technologies | 10 | 4 | 2 | 0 | Aug 24, 2018 (Z-0174-2019) |
| Affymetrix | 1 | 4 | 6 | 0 | Apr 14, 2016 (Z-1909-2016) |
| Fisher Scientific | 2 | 0 | 1 | 0 | Feb 5, 2014 (Z-1521-2014) |
| Patheon Manufacturing Services | 0 | 0 | 27 | 0 | — |
| Patheon Italia | 0 | 0 | 24 | 0 | — |
| Patheon Softgels | 0 | 0 | 17 | 0 | — |
| Patheon Pharmaceuticals | 0 | 0 | 16 | 0 | — |
| Patheon | 0 | 0 | 15 | 0 | — |
| Patheon Puerto Rico | 0 | 0 | 12 | 0 | — |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Nov 20, 2024 | Saint Louis, MO | Drugs | Voluntary Action Indicated (VAI) | 3003418999 |
| Aug 21, 2024 | Groningen, Netherlands | Drugs | Voluntary Action Indicated (VAI) | 3002608687 |
| Dec 8, 2023 | Saint Louis, MO | Drugs | Voluntary Action Indicated (VAI) | 3003418999 |
| Mar 28, 2023 | Groningen, Netherlands | Drugs | No Action Indicated (NAI) | 3002608687 |
| Mar 2, 2023 | Saint Louis, MO | Drugs | Voluntary Action Indicated (VAI) | 3003418999 |
| Nov 9, 2021 | Groningen, Netherlands | Drugs | Voluntary Action Indicated (VAI) | 3002608687 |
| Aug 2, 2019 | Saint Louis, MO | Drugs | Voluntary Action Indicated (VAI) | 3003418999 |
| Nov 14, 2014 | Groningen, Netherlands | Drugs | No Action Indicated (NAI) | 3002608687 |
| Feb 21, 2014 | Saint Louis, MO | Drugs | Voluntary Action Indicated (VAI) | 3003418999 |
| Apr 3, 2012 | Saint Louis, MO | Drugs | No Action Indicated (NAI) | 3003418999 |
| Jul 9, 2010 | Groningen, Netherlands | Drugs | Voluntary Action Indicated (VAI) | 3002608687 |
| Jun 23, 2010 | Saint Louis, MO | Drugs | Voluntary Action Indicated (VAI) | 3003418999 |
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3003418999 | Saint Louis, MO | 7 | Nov 20, 2024 |
| FEI 3002608687 | Groningen, Netherlands | 5 | Aug 21, 2024 |