1276277
Microvapor Devices LLC — FEI 3011528328
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- July 18, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- West Columbia, SC (United States)
Citations
| ID | CFR | Description |
|---|
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3193 | 21 CFR 820.30(g) | Design validation - simulated testing |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3309 | 21 CFR 820.120(b) | Examination for accuracy |
| 3313 | 21 CFR 820.120(d) | Records, DHR {see also 820.184(e)} |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |