FDA Inspection 1045232 — CC Wellness, LLC
The FDA completed an inspection of CC Wellness, LLC on March 21, 2018 in Valencia, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 21, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Valencia, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3159 | 21 CFR 820.184 | DHR content |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |