Eurofins BioPharma Product Testing Sweden AB FDA Record
- Latest inspection VAI · Jun 19, 2024
- No warning letters matched by name
Eurofins BioPharma Product Testing Sweden AB has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Eurofins BioPharma Product Testing Sweden AB" is on file.
- Latest inspection
- Jun 19, 2024 · VAI
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 | 9 | 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 Sweden AB: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 2 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 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 19, 2024 | Uppsala, Sweden | Drugs | Voluntary Action Indicated (VAI) | 3008759559 |
| Jun 19, 2024 | Uppsala, Sweden | Drugs | Voluntary Action Indicated (VAI) | 3008763211 |
| Dec 8, 2022 | Uppsala, Sweden | Drugs | Voluntary Action Indicated (VAI) | 3008763211 |
| Jun 27, 2019 | Uppsala, Sweden | Drugs | No Action Indicated (NAI) | 3008759559 |
| May 12, 2017 | Uppsala, Sweden | Drugs | No Action Indicated (NAI) | 3008763211 |
| Mar 13, 2015 | Uppsala, Sweden | Veterinary | Voluntary Action Indicated (VAI) | 3008763211 |
| Mar 9, 2015 | Uppsala, Sweden | Veterinary | No Action Indicated (NAI) | 3008759559 |
| Feb 18, 2011 | Uppsala, Sweden | Veterinary | Voluntary Action Indicated (VAI) | 3008763211 |
| Feb 16, 2011 | Uppsala, Sweden | Veterinary | Voluntary Action Indicated (VAI) | 3008759559 |
- 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 3008759559 | Uppsala, Sweden | 4 | Jun 19, 2024 |
| FEI 3008763211 | Uppsala, Sweden | 5 | Jun 19, 2024 |
Eurofins BioPharma Product Testing Sweden AB and the FDA: common questions
Has Eurofins BioPharma Product Testing Sweden AB received an FDA warning letter?
No FDA warning letter addressed to the name "Eurofins BioPharma Product Testing Sweden AB" 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 Sweden AB received an FDA Form 483?
FDA has not published a Form 483 for "Eurofins BioPharma Product Testing Sweden AB" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Eurofins BioPharma Product Testing Sweden AB?
The most recent FDA inspection on file ended Jun 19, 2024 at Uppsala, Sweden and was classified VAI. FDA has 9 inspections of Eurofins BioPharma Product Testing Sweden AB on file.
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