1102966
Tektone Sound & Signal Mfg.Inc. — FEI 3001757821
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 26, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Franklin, NC (United States)
Citations
| ID | CFR | Description |
|---|
| 21425 | 21 CFR 820.184(f) | DHR - UDI not included |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |