FDA Inspection 1275528 — Magnatone Hearing Aid Corp
The FDA completed an inspection of Magnatone Hearing Aid Corp on July 14, 2025 in Casselberry, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 14, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Casselberry, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |