FDA Inspection 992245 — Water-Jel Technologies, LLC
The FDA completed an inspection of Water-Jel Technologies, LLC on November 4, 2016 in Huntersville, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 4, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Huntersville, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |