Magnatone Hearing Aid Corp. Dba Persona Medical
170 N. Cypress Way, Casselberry, FL, US
Registered product codes
5 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 1044692.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jul 14, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Jul 14, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
7 on file
Top cited requirements
Compare to industry ↗21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
121 CFR 820.20(a)Management ensuring quality policy is understood
121 CFR 820.22Quality Audit/Reaudit - conducted
121 CFR 820.40(b)Change records, content
121 CFR 820.50Purchasing controls, Lack of or inadequate procedures
121 CFR 820.100(a)Lack of or inadequate procedures
1
- 21 CFR 803.17(a)(2)Jul 14, 2025
Lack of System for Determining MDR Events
- 21 CFR 820.20(a)Jul 14, 2025
Management ensuring quality policy is understood
- 21 CFR 820.22Jul 14, 2025
Quality Audit/Reaudit - conducted
- 21 CFR 820.40(b)Jul 14, 2025
Change records, content
- 21 CFR 820.50Jul 14, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.100(a)Jul 14, 2025
Lack of or inadequate procedures
- 21 CFR 820.198(a)Jul 14, 2025
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.