FDA Inspection 1170211 — Ear Technology Corporation
The FDA completed an inspection of Ear Technology Corporation on May 24, 2022 in Johnson City, TN. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- May 24, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Johnson City, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |