FDA Inspection 1246763 — ABV Electronics, Inc
The FDA completed an inspection of ABV Electronics, Inc on Aug 15, 2024 in Suwanee, GA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 15, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Suwanee, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |