FDA Inspection 788443 — Tissue Bank International/The National Eye Bank Center
The FDA completed an inspection of Tissue Bank International/The National Eye Bank Center on June 20, 2012 in Memphis, TN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 20, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Memphis, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12364 | 21 CFR 1271.195(c) | Monitoring-microorganisms where appropriate |
| 12401 | 21 CFR 1271.230(b) | Reduced risk representation |
| 12415 | 21 CFR 1271.260(e) | Temperature limits |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |