FEI 3031025053
Blue Elephant Inc
6716 Greenleaf Ave, Whittier, CA, US
MDR events0All time
Recalls0All time
Registered products2
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
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 3031025053.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)May 16, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)May 16, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
9 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.25(b)May 16, 2025
Training records
- 21 CFR 820.30(b)May 16, 2025
Design plans - Lack of or inadequate
- 21 CFR 820.30(c)May 16, 2025
Design input - documentation
- 21 CFR 820.30(d)May 16, 2025
Design output - documentation
- 21 CFR 820.30(e)May 16, 2025
Design review - documentation
- 21 CFR 820.30(f)May 16, 2025
Design verification - documentation
- 21 CFR 820.30(j)May 16, 2025
Design history file
- 21 CFR 820.50(a)(3)May 16, 2025
Acceptable supplier records, inadequate records
- 21 CFR 820.181May 16, 2025
DMR - not or inadequately maintained
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.