884950
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 28, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Johnston, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12203 | 21 CFR 606.170(a) | Adverse Reaction- Reports of Investigations |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 41 | 21 CFR 606.40(a)(1) | Provide space for examination |