FDA Inspection 857573 — Legacy Pharmaceutical Packaging LLC
The FDA completed an inspection of Legacy Pharmaceutical Packaging LLC on November 26, 2013 in Earth City, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 26, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- 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 |