FEI 3003067608
Focus Medical, Llc.
23 FRANCIS J. CLARKE CIRCLE, Bethel, CT, US
MDR events1All time
Recalls0All time
Registered products6
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
Registered product codes
6 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 3003067608.
FDA inspections
3 on file
- Voluntary Action Indicated (VAI)May 2, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)May 2, 2025
Postmarket Assurance: Devices · Citations posted
- Official Action Indicated (OAI)May 2, 2025
Radiation Control and Health Safety Act · Citations posted
Inspection citations
8 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.70(a)May 2, 2025
Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.184May 2, 2025
DHR content
- 21 CFR 820.198(c)May 2, 2025
Investigation of device failures
- 21 CFR 1010.3(a)(1)May 2, 2025
ID label lacks name and address
- 21 CFR 1040.10(g)(3)May 2, 2025
Class IV "Danger" label
- 21 CFR 1040.10(h)(1)(iii)May 2, 2025
Legible reproductions
- 21 CFR 1040.11(a)(2)May 2, 2025
Calibration of measurement system
- 21 CFR 1040.11(a)(3)May 2, 2025
Aperture label
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.