FDA Inspection 972183 — South Dakota Lions Eye Bank, Inc.
The FDA completed an inspection of South Dakota Lions Eye Bank, Inc. on April 7, 2016 in Sioux Falls, SD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 7, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Sioux Falls, SD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12395 | 21 CFR 1271.225 | Verification/validation |