1000459
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 28, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Johns Island, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 4354 | 21 CFR 211.165(d) | Acceptance/Rejection Levels |