FDA Inspection 969067 — Lions Eye Bank Of Delaware Valley, Inc.
The FDA completed an inspection of Lions Eye Bank Of Delaware Valley, Inc. on Mar 30, 2016 in Philadelphia, PA. 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
- Mar 30, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Philadelphia, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |
| 12405 | 21 CFR 1271.250(a) | Controlling the labeling of HCT/Ps |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |