Comfortland International, Llc
709 A O SMITH RD, Mebane, NC, US
Registered product codes
13 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 3008724689.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jun 12, 2026
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Jun 12, 2026
Postmarket Assurance: Devices · Citations posted
Inspection citations
8 on file
Top cited requirements
Compare to industry ↗21 CFR 801.20(a)Label to bear a unique device identifier
121 CFR 803.17Lack of Written MDR Procedures
1ISO 13485:2016 Clause 4.1.1QMS not documented and maintained adequately
1ISO 13485:2016 Clause 4.1.5Control over outsourced processes not proportionate to risk
1ISO 13485:2016 Clause 7.1Processes needed for product realization not planned and developed
1ISO 13485:2016 Clause 7.3.10Design and development files not maintained
1
- 21 CFR 801.20(a)Jun 12, 2026
Label to bear a unique device identifier
- 21 CFR 803.17Jun 12, 2026
Lack of Written MDR Procedures
- ISO 13485:2016 Clause 4.1.1Jun 12, 2026
QMS not documented and maintained adequately
- ISO 13485:2016 Clause 4.1.5Jun 12, 2026
Control over outsourced processes not proportionate to risk
- ISO 13485:2016 Clause 7.1Jun 12, 2026
Processes needed for product realization not planned and developed
- ISO 13485:2016 Clause 7.3.10Jun 12, 2026
Design and development files not maintained
- ISO 13485:2016 Clause 7.5.1Jun 12, 2026
Production and service provision not adequate
- ISO 13485:2016 Clause 8.2.2Jun 12, 2026
Complaint handling records not 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.