Alexion Pharma International Operations Unlimited Co. FDA Record
- Latest inspection VAI · May 17, 2024
- No warning letters matched by name
Alexion Pharma International Operations Unlimited Co. has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Alexion Pharma International Operations Unlimited Co." is on file.
- Latest inspection
- May 17, 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 | 4 | 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
Alexion Pharma International Operations Unlimited Co.: 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 | 1 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 17, 2024 | Athlone, Ireland | Drugs | Voluntary Action Indicated (VAI) | 3011532960 |
| Oct 27, 2023 | Dublin 15, Ireland | Drugs | Voluntary Action Indicated (VAI) | 3012889718 |
| Oct 25, 2019 | Athlone, Ireland | Drugs | Voluntary Action Indicated (VAI) | 3011532960 |
| May 2, 2018 | Dublin 15, Ireland | Drugs | No Action Indicated (NAI) | 3012889718 |
- 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 3011532960 | Athlone, Ireland | 2 | May 17, 2024 |
| FEI 3012889718 | Dublin 15, Ireland | 2 | Oct 27, 2023 |
Alexion Pharma International Operations Unlimited Co. and the FDA: common questions
Has Alexion Pharma International Operations Unlimited Co. received an FDA warning letter?
No FDA warning letter addressed to the name "Alexion Pharma International Operations Unlimited Co." 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 Alexion Pharma International Operations Unlimited Co. received an FDA Form 483?
FDA has not published a Form 483 for "Alexion Pharma International Operations Unlimited Co." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Alexion Pharma International Operations Unlimited Co.?
The most recent FDA inspection on file ended May 17, 2024 at Athlone, Ireland and was classified VAI. FDA has 4 inspections of Alexion Pharma International Operations Unlimited Co. on file.
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