Company
United KingdomWardray Premise Ltd, Brighouse, United Kingdom – FDA Inspections
Inspection records and compliance data for Wardray Premise Ltd in Brighouse, -. 2 FDA inspections on record (1 OAI), 2 Form 483s, last inspected January 09, 2025.
Company Profile
This profile covers Wardray Premise Ltd based in Brighouse, United Kingdom.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected October 11, 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 · Compliance: Medical Devices | 1261293 |
| October 11, 2017 | Not classified | Medical Devices & Rad Health | 1028350 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Wardray Premise Ltd
FEI Number
3009530228
Address
Unit 2, Springvale Works; Elland Road, Brighouse, - -, United Kingdom
Country
United Kingdom
ID: 2cb0e496-9340-4b59-b6b4-aac171158c1f