FEI 3025186177
Hi Tech Electronic Manufacturing Corporation
1938 Avenida Del Oro, Oceanside, CA, US
MDR events0All time
Recalls0All time
Registered products3
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
3 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 3025186177.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Feb 6, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Feb 6, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(h)Feb 6, 2025
Design transfer - Lack of or inadequate procedures
- 21 CFR 820.75(a)Feb 6, 2025
Documentation
- 21 CFR 820.184Feb 6, 2025
Lack of or inadequate DHR 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.