FDA Inspection 1298226 — Skytronics Led, Inc
The FDA completed an inspection of Skytronics Led, Inc on January 12, 2026 in Burbank, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
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 |