1060963
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 25, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brookings, SD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |