FDA Inspection 869445 — South Dakota Lions Eye and Tissue Bank Inc
The FDA completed an inspection of South Dakota Lions Eye and Tissue Bank Inc on February 28, 2014 in Rapid City, SD. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 28, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Rapid City, SD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12378 | 21 CFR 1271.210(d)(1) | Receipt documentation maintained |
| 12414 | 21 CFR 1271.260(d) | Corrective actions |
| 15020 | 21 CFR 1271.200(e) | Documentation of maintenance and cleaning |