Bioreliance Ltd.
Bioreliance Ltd. has 0 FDA recalls, 35 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest inspection
- May 13, 2026 · VAI
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 35 | Nov 13, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 2 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 4 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 4 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 2 | 0 | 0 | 0 | 0 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 13, 2026 | Glasgow, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3005343934 |
| Jan 29, 2026 | Rockville, MD | Drugs | Voluntary Action Indicated (VAI) | 1122041 |
| Dec 5, 2025 | Glasgow, United Kingdom | Biologics | Voluntary Action Indicated (VAI) | 3005343934 |
| Nov 22, 2024 | Rockville, MD | Biologics | Voluntary Action Indicated (VAI) | 1122041 |
| Nov 7, 2023 | Stirling, Scotland, United Kingdom | Biologics | No Action Indicated (NAI) | 3005619549 |
| Nov 7, 2023 | Penicuik, United Kingdom | Biologics | No Action Indicated (NAI) | 3005619544 |
| Nov 7, 2023 | Glasgow, United Kingdom | Biologics | No Action Indicated (NAI) | 3005343934 |
| Aug 4, 2023 | Rockville, MD | Drugs | No Action Indicated (NAI) | 1122041 |
| Jun 30, 2022 | Stirling, Scotland, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3005619549 |
| Mar 17, 2021 | Glasgow, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3005343934 |
| Sep 27, 2019 | Glasgow, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3005343934 |
| Mar 21, 2019 | Stirling, Scotland, United Kingdom | Biologics | Voluntary Action Indicated (VAI) | 3005619549 |
| Mar 21, 2019 | Penicuik, United Kingdom | Biologics | Voluntary Action Indicated (VAI) | 3005619544 |
| Mar 15, 2019 | Glasgow, United Kingdom | Biologics | Voluntary Action Indicated (VAI) | 3005343934 |
| Jul 13, 2018 | Rockville, MD | Drugs | Voluntary Action Indicated (VAI) | 1122041 |
| Oct 10, 2017 | Stirling, Scotland, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3005619549 |
| Sep 22, 2017 | Glasgow, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3005343934 |
| Sep 7, 2016 | Penicuik, United Kingdom | Drugs | No Action Indicated (NAI) | 3005619544 |
| Mar 17, 2016 | Stirling, Scotland, United Kingdom | Biologics | Voluntary Action Indicated (VAI) | 3005619549 |
| Mar 17, 2016 | Penicuik, United Kingdom | Biologics | No Action Indicated (NAI) | 3005619544 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Bioreliance Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3005343934 | Glasgow, United Kingdom | 11 | May 13, 2026 |
| FEI 1122041 | Rockville, MD | 11 | Jan 29, 2026 |
| FEI 3005619544 | Penicuik, United Kingdom | 5 | Nov 7, 2023 |
| FEI 3005619549 | Stirling, Scotland, United Kingdom | 8 | Nov 7, 2023 |
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