1129967
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 25, 2020
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Mineola, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |