FDA Inspection 1165956 — WAVi Co.
The FDA completed an inspection of WAVi Co. on March 31, 2022 in Denver, CO. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 31, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Denver, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |