FEI 3012903018
Unique Safety Equipment Co., Ltd.
1F, No.16. Lane 130, Ming Chuan Rd., New Taipei City, TW
MDR events0All time
Recalls0All time
Registered products2
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
2 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3012903018.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)May 29, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)May 29, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.40May 29, 2025
Procedures not adequately established or maintained
- 21 CFR 820.75(a)May 29, 2025
Lack of or inadequate process validation
- 21 CFR 820.90(a)May 29, 2025
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)May 29, 2025
Lack of or inadequate procedures
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.