1298226
Skytronics Led, Inc — FEI 3012259838
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 12, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Burbank, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 1845 | 21 CFR 211.84(d)(3) | Container/Closure Written Test Procedure |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2404 | 21 CFR 211.194(a)(6) | Comparison of Test Results to Specifications |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |