Company
United KingdomSharp U.K. Manufacturing (SUKM), Wrexham, United Kingdom – FDA Inspections
Inspection records and compliance data for Sharp U.K. Manufacturing (SUKM) in Wrexham. 2 FDA inspections on record (1 OAI), 1 Form 483, last inspected April 23, 2018.
Company Profile
This profile covers Sharp U.K. Manufacturing (SUKM) based in Wrexham, United Kingdom.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected May 3, 2016. Last inspected April 23, 2018.
Most cited issue areas
- tests--errors and uncertainties accounted for2 inspections
- Certification not based on adequate test/testing program1 inspection
- Door position1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 23, 2018 | VAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1050399 |
| May 3, 2016 | OAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 970679 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Sharp U.K. Manufacturing (SUKM)
FEI Number
3000219245
Address
Sharp House, Davy Way; Llay Industrial Estate, Wrexham, United Kingdom
Country
United Kingdom
ID: 2b48be2b-4595-41c2-b616-2af5bee1256a