FEI 3015200653
Exotoe Llc
520 Elliot St, Charlotte, NC, US
MDR events1All time
Recalls0All time
Registered products1
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
Registered product codes
1 product codes
Recent MDR events
1 on file
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3015200653.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Nov 21, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Nov 21, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
5 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(g)Nov 21, 2024
Design validation - simulated testing
- 21 CFR 820.30(h)Nov 21, 2024
Design transfer - Lack of or inadequate procedures
- 21 CFR 820.80(d)Nov 21, 2024
Lack of or inadequate final acceptance procedures
- 21 CFR 820.100(a)Nov 21, 2024
Lack of or inadequate procedures
- 21 CFR 820.184Nov 21, 2024
DHR content
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.