FDA Inspection
WARDRAY PREMISE LTDWARDRAY PREMISE LTD – FDA Inspection, Jan 9, 2025
Record Details
This FDA Inspection record concerns WARDRAY PREMISE LTD, with an inspection on January 9, 2025, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c2992da0-0bed-45b1-89fd-2fa8e4310fe8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1261293
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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Other FDA inspections of WARDRAY PREMISE LTD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 13, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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