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933826

Legacy Pharmaceutical Packaging LLC — FEI 3004453700

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 9, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Earth City, MO (United States)

Facility

Other inspections at this facility

  • 1229505 (VAI Thu Feb 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1210234 (OAI Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1208390 (VAI Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1169547 (OAI Wed Apr 27 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1115769 (VAI Thu Jan 16 2020 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
135821 CFR 211.100(b)SOPs not followed / documented
145421 CFR 211.115(a)Reprocessing procedures not written or followed
197621 CFR 211.182Specific information required in individual logs
197921 CFR 211.182Chronological Order of Equipment Log Entries
359121 CFR 211.110(b)In-process materials specifications
440221 CFR 211.192Written record of investigation incomplete