FDA Inspection 857573 — Legacy Pharmaceutical Packaging LLC
The FDA completed an inspection of Legacy Pharmaceutical Packaging LLC on Nov 26, 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). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 26, 2013
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Earth City, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1496 | 21 CFR 211.122(a) | Sampling/testing of labeling/packaging materials |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4576 | 21 CFR 211.192 | No written record of investigation |