FDA Inspection 1112331 — Magnatone Hearing Aid Corp
The FDA completed an inspection of Magnatone Hearing Aid Corp on Dec 10, 2019 in Casselberry, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Dec 10, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Casselberry, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |