FEI 1930126
Delasco, Llc
4001 E Plano Pkwy Ste 100, Plano, TX, US
MDR events0All time
Recalls0All time
Registered products34
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
Registered product codes
34 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 1930126.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jan 14, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Jan 14, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 803.17Jan 14, 2025
Lack of Written MDR Procedures
- 21 CFR 820.80(a)Jan 14, 2025
Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Jan 14, 2025
Lack of or inadequate procedures
- 21 CFR 820.198(a)Jan 14, 2025
Lack of or inadequate complaint 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.