FDA Inspection 1149069 — Water-Jel Technologies, LLC
The FDA completed an inspection of Water-Jel Technologies, LLC on Aug 18, 2021 in Huntersville, NC. 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
- Aug 18, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Huntersville, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |