FDA Inspection 1228348 — Avox Systems Inc
The FDA completed an inspection of Avox Systems Inc on February 2, 2024 in Lancaster, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 2, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lancaster, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |