Pfizer Ireland Pharmaceuticals Unlimited Company FDA Record
Pfizer Ireland Pharmaceuticals Unlimited Company has 0 FDA recalls, 25 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Pfizer Ireland Pharmaceuticals Unlimited Company" is on file.
- Latest recall
- D-0052-2027 · Sep 29, 2026 · filed under Pfizer
- Latest inspection
- Oct 25, 2024 · VAI
Newer recall under related name Pfizer: Sep 29, 2026, D-0052-2027.
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 | 25 | 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
| 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 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 2 | 0 | 0 | 0 | 0 |
| 2018 | 5 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Oct 25, 2024 | Ringaskiddy, Ireland | Drugs | Voluntary Action Indicated (VAI) | 3002807852 |
| Dec 15, 2023 | Dublin 22, Ireland | Drugs | Voluntary Action Indicated (VAI) | 3004145594 |
| Sep 23, 2022 | Newbridge, Ireland | Drugs | Voluntary Action Indicated (VAI) | 3006785053 |
| Nov 12, 2019 | Dublin 22, Ireland | Biologics | Voluntary Action Indicated (VAI) | 3004145594 |
| Sep 27, 2019 | Newbridge, Ireland | Drugs | Voluntary Action Indicated (VAI) | 3006785053 |
| Nov 9, 2018 | Dublin 22, Ireland | Drugs | Voluntary Action Indicated (VAI) | 3004145594 |
| Sep 18, 2018 | Dublin 22, Ireland | Biologics | Voluntary Action Indicated (VAI) | 3004145594 |
| Aug 17, 2018 | Ringaskiddy, Ireland | Drugs | Voluntary Action Indicated (VAI) | 3002807852 |
| Apr 13, 2018 | Newbridge, Ireland | Drugs | No Action Indicated (NAI) | 3006785053 |
| Jan 26, 2018 | Ringaskiddy, Ireland | Drugs | Voluntary Action Indicated (VAI) | 3002807852 |
| Mar 10, 2017 | Dublin 22, Ireland | Drugs | Voluntary Action Indicated (VAI) | 3004145594 |
| Sep 20, 2016 | Dublin 22, Ireland | Biologics | Voluntary Action Indicated (VAI) | 3004145594 |
| Jul 29, 2016 | Newbridge, Ireland | Drugs | Voluntary Action Indicated (VAI) | 3006785053 |
| Apr 29, 2016 | Ringaskiddy, Ireland | Drugs | No Action Indicated (NAI) | 3002807852 |
| Jun 12, 2015 | Newbridge, Ireland | Drugs | Voluntary Action Indicated (VAI) | 3006785053 |
| Aug 1, 2014 | Ringaskiddy, Ireland | Drugs | Voluntary Action Indicated (VAI) | 3002807852 |
| Jun 17, 2014 | Dublin 22, Ireland | Biologics | Voluntary Action Indicated (VAI) | 3004145594 |
| Oct 15, 2013 | Dublin 22, Ireland | Drugs | No Action Indicated (NAI) | 3004145594 |
| Feb 8, 2013 | Newbridge, Ireland | Drugs | No Action Indicated (NAI) | 3006785053 |
| Jun 28, 2012 | Dublin 22, Ireland | Biologics | Voluntary Action Indicated (VAI) | 3004145594 |
- 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 3002807852 | Ringaskiddy, Ireland | 6 | Oct 25, 2024 |
| FEI 3004145594 | Dublin 22, Ireland | 11 | Dec 15, 2023 |
| FEI 3006785053 | Newbridge, Ireland | 8 | Sep 23, 2022 |
Pfizer Ireland Pharmaceuticals Unlimited Company and the FDA: common questions
Has Pfizer Ireland Pharmaceuticals Unlimited Company received an FDA warning letter?
No FDA warning letter addressed to the name "Pfizer Ireland Pharmaceuticals Unlimited Company" 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 Pfizer Ireland Pharmaceuticals Unlimited Company received an FDA Form 483?
FDA has not published a Form 483 for "Pfizer Ireland Pharmaceuticals Unlimited Company" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Pfizer Ireland Pharmaceuticals Unlimited Company?
The most recent FDA inspection on file ended Oct 25, 2024 at Ringaskiddy, Ireland and was classified VAI. FDA has 25 inspections of Pfizer Ireland Pharmaceuticals Unlimited Company on file.
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