FDA Inspection 835583 — Legacy Pharmaceutical Packaging LLC
The FDA completed an inspection of Legacy Pharmaceutical Packaging LLC on Jun 18, 2013 in Earth City, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 18, 2013
- Fiscal Year
- 2013
- 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 |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1774 | 21 CFR 211.142(a) | Quarantine - actual practice |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1798 | 21 CFR 211.82(b) | Quarantine Storage of Components |
| 3569 | 21 CFR 211.89 | Quarantine of Rejected Components et. al. |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |