Company
United KingdomWARDRAY PREMISE LTD, Sutton, United Kingdom – FDA Inspections
Inspection records and compliance data for WARDRAY PREMISE LTD in Sutton. 2 FDA inspections on record (1 OAI), 1 Form 483, last inspected January 09, 2025.
Company Profile
This profile covers WARDRAY PREMISE LTD based in Sutton, United Kingdom.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected October 13, 2017. Last inspected January 9, 2025.
Most cited issue areas
- Devices subject to device identification GUDID data submission requirements.1 inspection
- Label to bear a unique device identifier1 inspection
- Lack of System for Determining MDR Events1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 9, 2025 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1261293 |
| October 13, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1030855 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
WARDRAY PREMISE LTD
FEI Number
3007912863
Address
2 Mulgrave Chambers, 28/28 Mulgrave Road, Sutton, United Kingdom
Country
United Kingdom
ID: 1a979f53-2461-4dcb-999e-d4f9f93737a5