Catalent U.K. Swindon Zydis Limited FDA Record
Catalent U.K. Swindon Zydis Limited has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Catalent U.K. Swindon Zydis Limited" is on file.
- Latest inspection
- Oct 10, 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 | 8 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 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 |
|---|---|---|---|---|
| Oct 10, 2024 | Swindon, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3003812585 |
| Jun 15, 2023 | Swindon, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3003812585 |
| Feb 20, 2020 | Swindon, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3003812585 |
| Jul 26, 2018 | Swindon, United Kingdom | Biologics | Voluntary Action Indicated (VAI) | 3003812585 |
| Sep 15, 2016 | Swindon, United Kingdom | Drugs | No Action Indicated (NAI) | 3003812585 |
| Sep 6, 2016 | Swindon, United Kingdom | Biologics | Voluntary Action Indicated (VAI) | 3003812585 |
| Sep 12, 2014 | Swindon, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3003812585 |
| Nov 18, 2011 | Swindon, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3003812585 |
- 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 3003812585 | Swindon, United Kingdom | 8 | Oct 10, 2024 |
Catalent U.K. Swindon Zydis Limited and the FDA: common questions
Has Catalent U.K. Swindon Zydis Limited received an FDA warning letter?
No FDA warning letter addressed to the name "Catalent U.K. Swindon Zydis 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 Catalent U.K. Swindon Zydis Limited received an FDA Form 483?
FDA has not published a Form 483 for "Catalent U.K. Swindon Zydis Limited" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Catalent U.K. Swindon Zydis Limited?
The most recent FDA inspection on file ended Oct 10, 2024 at Swindon, United Kingdom and was classified VAI. FDA has 8 inspections of Catalent U.K. Swindon Zydis Limited on file.
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