FDA Inspection 654651 — Saving Sight
The FDA completed an inspection of Saving Sight on Mar 30, 2010 in Springfield, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 30, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Springfield, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12311 | 21 CFR 1271.160(b)(1) | Ensuring appropriate core requirements followed |
| 12414 | 21 CFR 1271.260(d) | Corrective actions |
| 12427 | 21 CFR 1271.265(c)(3) | HCT/Ps made under departure from process |
| 12472 | 21 CFR 1271.350(b)(1) | Deviations not investigated |
| 12473 | 21 CFR 1271.350(b)(2) | Deviations not reported to FDA |