Manamed Llc
2612 Sirius Drive, Denton, TX, US
Registered product codes
26 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 3011767724.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)May 21, 2024
Compliance: Devices · Citations posted
Inspection citations
7 on file
Top cited requirements
Compare to industry ↗21 CFR 803.17Lack of Written MDR Procedures
121 CFR 820.30(a)Design control - no procedures
121 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
121 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
121 CFR 820.100(a)Lack of or inadequate procedures
121 CFR 820.181DMR - not or inadequately maintained
1
- 21 CFR 803.17May 21, 2024
Lack of Written MDR Procedures
- 21 CFR 820.30(a)May 21, 2024
Design control - no procedures
- 21 CFR 820.50(a)May 21, 2024
Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.80(a)May 21, 2024
Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)May 21, 2024
Lack of or inadequate procedures
- 21 CFR 820.181May 21, 2024
DMR - not or inadequately maintained
- 21 CFR 820.184May 21, 2024
DHR - not or inadequately 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.