840156
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 18, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Oakdale, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |