Eurofins Biopharma Product Testing Ireland Limited FDA Record
- Latest inspection NAI · Jun 20, 2025
- No warning letters matched by name
Eurofins Biopharma Product Testing Ireland Limited has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Eurofins Biopharma Product Testing Ireland Limited" is on file.
- Latest inspection
- Jun 20, 2025 · NAI
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 | 6 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Eurofins Biopharma Product Testing Ireland Limited: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 20, 2025 | Dungarvan, Ireland | Biologics | No Action Indicated (NAI) | 3002807550 |
| May 26, 2023 | Dungarvan, Ireland | Drugs | Voluntary Action Indicated (VAI) | 3002807550 |
| Jan 17, 2019 | Dungarvan, Ireland | Drugs | Voluntary Action Indicated (VAI) | 3002807550 |
| Feb 24, 2017 | Dungarvan, Ireland | Drugs | No Action Indicated (NAI) | 3002807550 |
| Mar 29, 2013 | Dungarvan, Ireland | Drugs | No Action Indicated (NAI) | 3002807550 |
| Sep 30, 2009 | Dungarvan, Ireland | Drugs | No Action Indicated (NAI) | 3002807550 |
- 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.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3002807550 | Dungarvan, Ireland | 6 | Jun 20, 2025 |
Eurofins Biopharma Product Testing Ireland Limited and the FDA: common questions
Has Eurofins Biopharma Product Testing Ireland Limited received an FDA warning letter?
No FDA warning letter addressed to the name "Eurofins Biopharma Product Testing Ireland Limited" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Eurofins Biopharma Product Testing Ireland Limited received an FDA Form 483?
FDA has not published a Form 483 for "Eurofins Biopharma Product Testing Ireland Limited" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Eurofins Biopharma Product Testing Ireland Limited?
The most recent FDA inspection on file ended Jun 20, 2025 at Dungarvan, Ireland and was classified NAI. FDA has 6 inspections of Eurofins Biopharma Product Testing Ireland Limited on file.
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