FDA Inspection 1018119 — Magnatone Hearing Aid Corp
The FDA completed an inspection of Magnatone Hearing Aid Corp on July 14, 2017 in Casselberry, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- July 14, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Casselberry, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 537 | 21 CFR 820.70(a) | Production processes |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |