R-med, Inc.
3465 NAVARRE AVENUE, OREGON, OH, US
Registered product codes
1 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 1000305979.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Apr 23, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Apr 23, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
10 on file
Top cited requirements
Compare to industry ↗21 CFR 820.20(c)Management review - defined interval, sufficient frequency
121 CFR 820.22Quality Audit/Reaudit - conducted
121 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
121 CFR 820.30(j)Design history file
121 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
121 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
1
- 21 CFR 820.20(c)Apr 23, 2025
Management review - defined interval, sufficient frequency
- 21 CFR 820.22Apr 23, 2025
Quality Audit/Reaudit - conducted
- 21 CFR 820.30(g)Apr 23, 2025
Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(j)Apr 23, 2025
Design history file
- 21 CFR 820.80(a)Apr 23, 2025
Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.90(a)Apr 23, 2025
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.181Apr 23, 2025
DMR - not or inadequately maintained
- 21 CFR 820.184Apr 23, 2025
DHR - not or inadequately maintained
- 21 CFR 820.198(a)Apr 23, 2025
Complaints
- 21 CFR 820.250(a)Apr 23, 2025
Statistical techniques - 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.