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794472

Lotte Biologics USA, LLC — FEI 1317757

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 20, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
East Syracuse, NY (United States)

Facility

Other inspections at this facility

  • 1246771 (NAI Thu Sep 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1093554 (VAI Wed Jun 05 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1010187 (VAI Fri Apr 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 897857 (VAI Thu Sep 25 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 676856 (NAI Fri Aug 20 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
1570621 CFR 111.325(a)Laboratory operations: electronic
203121 CFR 211.194(a)Complete test data included in records