FDA Inspection 863188 — CC Wellness, LLC
The FDA completed an inspection of CC Wellness, LLC on Jan 30, 2014 in Valencia, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 30, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Valencia, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |