FDA Inspection 933826 — Legacy Pharmaceutical Packaging LLC
The FDA completed an inspection of Legacy Pharmaceutical Packaging LLC on Jul 9, 2015 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
- Jul 9, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Earth City, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 1979 | 21 CFR 211.182 | Chronological Order of Equipment Log Entries |
| 3591 | 21 CFR 211.110(b) | In-process materials specifications |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |