FDA Inspection 1249649 — Water-Jel Technologies, LLC
The FDA completed an inspection of Water-Jel Technologies, LLC on Sep 20, 2024 in Huntersville, NC. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Sep 20, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Huntersville, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |