1210234

Legacy Pharmaceutical Packaging LLC — FEI 3004453700

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 30, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Earth City, MO (United States)

Citations

IDCFRDescription
111121 CFR 211.25(a)Training , Education , Experience overall
121521 CFR 211.67(b)Written procedures not established/followed
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
135821 CFR 211.100(b)SOPs not followed / documented
163621 CFR 211.130(e)Packaging line inspection before use
202721 CFR 211.192Investigations of discrepancies, failures