1145185
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- July 1, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Williamsville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12287 | 21 CFR 1271.80(c) | Kits not FDA approved, specifically labeled |
| 12319 | 21 CFR 1271.160(b)(3) | Actions taken and documented |