FDA Inspection
LockDown Medical Ltd.LockDown Medical Ltd. – FDA Inspection, Jun 5, 2014
Record Details
This FDA Inspection record concerns LockDown Medical Ltd., with an inspection on June 5, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- LockDown Medical Ltd.
- Inspection Date
- June 5, 2014
- Product Type
- Devices
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ID · f802cee4-8e3f-4cc0-a95c-6b321fe5c02b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 883926
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.120Lack of or inadequate procedures for labeling
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Other FDA inspections of LockDown Medical Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 3, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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