890208

Legacy Pharmaceutical Packaging LLC — FEI 3004453700

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 29, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Earth City, MO (United States)

Citations

IDCFRDescription
109821 CFR 211.22(c)Approve or reject procedures or specs
110521 CFR 211.22(d)Procedures not in writing, fully followed
135821 CFR 211.100(b)SOPs not followed / documented
136121 CFR 211.100(a)Absence of Written Procedures
202821 CFR 211.192Extent of discrepancy, failure investigations
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved