FEI 3021159346
Coronado Aesthetics Llc
601 State St Ste 200, Southlake, TX, 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 3021159346.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Aug 22, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Aug 22, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.20(c)Aug 22, 2025
Management review - defined interval, sufficient frequency
- 21 CFR 820.22Aug 22, 2025
Quality Audit/Reaudit - conducted
- 21 CFR 820.30(e)Aug 22, 2025
Design review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Aug 22, 2025
Design validation- 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.