FDA Inspection 1263678 — Vayuclear Inc
The FDA completed an inspection of Vayuclear Inc on March 14, 2025 in Charleston, SC. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 14, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Charleston, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 21424 | 21 CFR 820.120(b) | Labeling inspection - UDI |
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3149 | 21 CFR 820.180 | Availability |
| 3313 | 21 CFR 820.120(d) | Records, DHR {see also 820.184(e)} |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |