FDA Inspection 1208493 — Wello, Inc.
The FDA completed an inspection of Wello, Inc. on June 21, 2023 in Addison, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 21, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Addison, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |
| 3696 | 21 CFR 820.100(b) | Documentation |