1042813
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 2, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Gainesville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12400 | 21 CFR 1271.230(a) | Documented, dated, signed |
| 12402 | 21 CFR 1271.230(c) | Changes to validated process |
| 12473 | 21 CFR 1271.350(b)(2) | Deviations not reported to FDA |