Norton Healthcare Limited FDA Record
Norton Healthcare Limited has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Norton Healthcare Limited" is on file.
- Latest inspection
- Feb 10, 2023 · 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 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 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 |
|---|---|---|---|---|
| Feb 10, 2023 | Runcorn, United Kingdom | Drugs | No Action Indicated (NAI) | 3003925187 |
| Nov 26, 2021 | Runcorn, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3003925187 |
| Dec 13, 2018 | Runcorn, United Kingdom | Drugs | No Action Indicated (NAI) | 3003925187 |
| May 4, 2016 | Runcorn, United Kingdom | Drugs | No Action Indicated (NAI) | 3003925187 |
| Nov 11, 2014 | Runcorn, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3003925187 |
| Nov 6, 2012 | Runcorn, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3003925187 |
| Nov 19, 2010 | Runcorn, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3003925187 |
| Apr 22, 2009 | Runcorn, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3003925187 |
- 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 3003925187 | Runcorn, United Kingdom | 8 | Feb 10, 2023 |
Norton Healthcare Limited and the FDA: common questions
Has Norton Healthcare Limited received an FDA warning letter?
No FDA warning letter addressed to the name "Norton Healthcare 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 Norton Healthcare Limited received an FDA Form 483?
FDA has not published a Form 483 for "Norton Healthcare Limited" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Norton Healthcare Limited?
The most recent FDA inspection on file ended Feb 10, 2023 at Runcorn, United Kingdom and was classified NAI. FDA has 8 inspections of Norton Healthcare Limited on file.
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