FDA Inspection 680209 — Lions Eye Bank Of Wisconsin, Inc.
The FDA completed an inspection of Lions Eye Bank Of Wisconsin, Inc. on Sep 16, 2010 in Madison, WI. 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 16, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Madison, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12309 | 21 CFR 1271.160(a) | Program is appropriate for the HCT/Ps |
| 12319 | 21 CFR 1271.160(b)(3) | Actions taken and documented |
| 12326 | 21 CFR 1271.160(c) | Quality audits performed periodically |
| 12375 | 21 CFR 1271.210(a) | Use prior to verification |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |