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 Office of Inspections and Investigations, covering medical devices & rad health.
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ID · b8534e82-cbef-44f7-af69-d18e95f96e78
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
- Compliance: Medical Devices
- Outcome
- Form 483 issued
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 11, 2017 | Not classified | Office of Inspections and Investigations |
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