Omt, Llc
3848 SW 30th Ave, Fort Lauderdale, FL, US
Registered product codes
8 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 3005663073.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Mar 5, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Mar 5, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
8 on file
Top cited requirements
Compare to industry ↗21 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 records
121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
121 CFR 820.50Purchasing controls, Lack of or inadequate procedures
121 CFR 820.70(c)Environmental control Lack of or inadequate procedures
1
- 21 CFR 820.20(c)Mar 5, 2025
Management review - Lack of or inadequate procedures
- 21 CFR 820.22Mar 5, 2025
Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Mar 5, 2025
Training records
- 21 CFR 820.30(g)Mar 5, 2025
Design validation- Lack of or inadequate procedures
- 21 CFR 820.50Mar 5, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(c)Mar 5, 2025
Environmental control Lack of or inadequate procedures
- 21 CFR 820.80(e)Mar 5, 2025
Documentation
- 21 CFR 820.100(a)Mar 5, 2025
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.