FDA Inspection 769336 — Rocky Mountain Lions Eye Bank
The FDA completed an inspection of Rocky Mountain Lions Eye Bank on Feb 16, 2012 in Aurora, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 16, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Aurora, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12250 | 21 CFR 1271.55(d)(4) | Ten year retention |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12344 | 21 CFR 1271.190(a) | Lighting, ventilation, plumbing |