1013016
Packaging Group Corp — FEI 3010838254
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 6, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Michigan City, IN (United States)
Citations
| ID | CFR | Description |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |