FDA Inspection 808731 — Indiana Lions Eye Bank, Inc.
The FDA completed an inspection of Indiana Lions Eye Bank, Inc. on November 20, 2012 in Carmel, IN. 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
- November 20, 2012
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Carmel, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12320 | 21 CFR 1271.160(b)(3) | Actions verified, short and long term solutions |
| 12435 | 21 CFR 1271.270(a) | Records maintained concurrently |