FDA Inspection 985369 — Lions Eye Bank Of Wisconsin, Inc.
The FDA completed an inspection of Lions Eye Bank Of Wisconsin, Inc. on Sep 16, 2016 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 16, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Madison, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12311 | 21 CFR 1271.160(b)(1) | Ensuring appropriate core requirements followed |
| 12329 | 21 CFR 1271.160(d) | Documentation/approval prior to implementation |
| 12385 | 21 CFR 1271.150(c)(2) | Responsibility for review before distribution |
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |