FDA Inspection 653985 — Water-Jel Technologies, LLC
The FDA completed an inspection of Water-Jel Technologies, LLC on March 26, 2010 in Huntersville, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 26, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Huntersville, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4576 | 21 CFR 211.192 | No written record of investigation |