FDA Inspection 865613 — Saving Sight
The FDA completed an inspection of Saving Sight on February 19, 2014 in Kansas City, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 19, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Kansas City, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12337 | 21 CFR 1271.180(a) | Design adequate to bar spread of CD's |
| 12436 | 21 CFR 1271.270(a) | Accurate, indelible, legible |