LockDown Medical Ltd. FDA Record
- Latest inspection NAI · Jul 3, 2023
- Last warning letter 2014
LockDown Medical Ltd. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to LockDown Medical Ltd., the most recent on Sep 11, 2014.
- Latest inspection
- Jul 3, 2023 · 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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LockDown Medical Ltd. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Sep 11, 2014 · Record page |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 3, 2023 | Redditch, United Kingdom | Devices | No Action Indicated (NAI) | 3008237817 |
| Jun 5, 2014 | Redditch, United Kingdom | Devices | Official Action Indicated (OAI) | 3008237817 |
- 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 LockDown Medical Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3008237817 | Redditch, United Kingdom | 2 | Jul 3, 2023 |
LockDown Medical Ltd. and the FDA: common questions
Has LockDown Medical Ltd. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to LockDown Medical Ltd.. The most recent is dated Sep 11, 2014.
Has LockDown Medical Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "LockDown Medical Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect LockDown Medical Ltd.?
The most recent FDA inspection on file ended Jul 3, 2023 at Redditch, United Kingdom and was classified NAI. FDA has 2 inspections of LockDown Medical Ltd. on file, 1 of them classified OAI (official action indicated).
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