FDA Inspection 813313 — Florida Lions Eye Bank, Inc.
The FDA completed an inspection of Florida Lions Eye Bank, Inc. on December 6, 2012 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 6, 2012
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12301 | 21 CFR 1271.150(c)(1)(iii) | Ensurane of compliance |
| 12326 | 21 CFR 1271.160(c) | Quality audits performed periodically |
| 12364 | 21 CFR 1271.195(c) | Monitoring-microorganisms where appropriate |