Ablenet, Inc.
2625 PATTON RD, Roseville, MN, US
Registered product codes
2 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 3001576173.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jul 8, 2024
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Jul 8, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
8 on file
Top cited requirements
Compare to industry ↗21 CFR 803.17Lack of Written MDR Procedures
121 CFR 820.20(c)Management review - Lack of or inadequate procedures
121 CFR 820.22Quality audits - Lack of or inadequate procedures
121 CFR 820.25(b)Training - Lack of or inadequate procedures
121 CFR 820.50Purchasing controls, Lack of or inadequate procedures
121 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
1
- 21 CFR 803.17Jul 8, 2024
Lack of Written MDR Procedures
- 21 CFR 820.20(c)Jul 8, 2024
Management review - Lack of or inadequate procedures
- 21 CFR 820.22Jul 8, 2024
Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Jul 8, 2024
Training - Lack of or inadequate procedures
- 21 CFR 820.50Jul 8, 2024
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(a)Jul 8, 2024
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Jul 8, 2024
Lack of or inadequate procedures
- 21 CFR 820.198(a)Jul 8, 2024
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.