614518
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 3, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Salisbury, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |