FEI 3007210720
Rhausler, Inc.
39737 Paseo Padre Pkwy Ste D, Fremont, CA, US
MDR events0All time
Recalls0All time
Registered products3
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
Registered product codes
3 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 3007210720.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Dec 20, 2024
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Dec 20, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
6 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.20(b)(3)(i)Dec 20, 2024
Management representative implementing the quality system
- 21 CFR 820.20(e)Dec 20, 2024
Quality System Procedures
- 21 CFR 820.22Dec 20, 2024
Quality Audit/Reaudit - conducted
- 21 CFR 820.25(a)Dec 20, 2024
Personnel
- 21 CFR 820.100(b)Dec 20, 2024
Documentation
- 21 CFR 820.198(a)Dec 20, 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.