FDA Inspection 1210234 — Legacy Pharmaceutical Packaging LLC
The FDA completed an inspection of Legacy Pharmaceutical Packaging LLC on Jun 30, 2023 in Earth City, MO. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 30, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Earth City, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1636 | 21 CFR 211.130(e) | Packaging line inspection before use |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |