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FDA Inspection 1093554 — Lotte Biologics USA, LLC

Lotte Biologics USA, LLC — FEI 1317757

The FDA completed an inspection of Lotte Biologics USA, LLC on June 5, 2019 in East Syracuse, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 5, 2019
Fiscal Year
2019
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))
  • 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))
  • 794472 (VAI Fri Jul 20 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 676856 (NAI Fri Aug 20 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources