890208
Legacy Pharmaceutical Packaging LLC — FEI 3004453700
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 29, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Earth City, MO (United States)
Citations
| ID | CFR | Description |
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |