FEI 3011418975
Pneo, Llc
204 Cardinal Drive, Denton, TX, US
MDR events1All time
Recalls0All time
Registered products6
Establishment typeComplaintComplaint File Establishment per 21 CFR 820.198
Registered product codes
6 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 3011418975.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Nov 5, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Nov 5, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.25(b)Nov 5, 2025
Training - Lack of or inadequate procedures
- 21 CFR 820.70(i)Nov 5, 2025
Software validation for automated processes
- 21 CFR 820.198(c)Nov 5, 2025
Investigation of device failures
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.