Sterex Electrolysis Int Ltd FDA Record
- Latest inspection NAI · Nov 6, 2014
- Last warning letter 2013
Sterex Electrolysis Int Ltd has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Sterex Electrolysis Int Ltd, the most recent on Jun 24, 2013.
- Latest inspection
- Nov 6, 2014 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 2 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Sterex Electrolysis Int Ltd FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Jun 24, 2013 · Record page |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Nov 6, 2014 | Birmingham, United Kingdom | Devices | No Action Indicated (NAI) | 1000439607 |
| Feb 14, 2013 | Birmingham, United Kingdom | Devices | Official Action Indicated (OAI) | 1000439607 |
- 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.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Sterex Electrolysis Int Ltd: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1000439607 | Birmingham, United Kingdom | 2 | Nov 6, 2014 |
Sterex Electrolysis Int Ltd and the FDA: common questions
Has Sterex Electrolysis Int Ltd received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Sterex Electrolysis Int Ltd. The most recent is dated Jun 24, 2013.
Has Sterex Electrolysis Int Ltd received an FDA Form 483?
FDA has not published a Form 483 for "Sterex Electrolysis Int Ltd" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Sterex Electrolysis Int Ltd?
The most recent FDA inspection on file ended Nov 6, 2014 at Birmingham, United Kingdom and was classified NAI. FDA has 2 inspections of Sterex Electrolysis Int Ltd on file, 1 of them classified OAI (official action indicated).
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