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1216052

Hans Biomed Corporation — FEI 3003828812

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 25, 2023
Fiscal Year
2023
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Yuseong District (Korea (the Republic of))

Facility

Other inspections at this facility

  • 1282278 (VAI Fri Sep 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1091073 (NAI Fri Apr 05 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 966652 (VAI Thu Mar 31 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 893493 (VAI Tue Jun 03 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 848720 (VAI Thu Aug 29 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1235721 CFR 1271.195(a)(1)Temperature and humidity controls
1236321 CFR 1271.195(c)Monitoring--cross contamination, exposure to CD
1236521 CFR 1271.195(d)Documentation not maintained
1237521 CFR 1271.210(a)Use prior to verification
1243721 CFR 1271.270(a)Records incomplete
1502021 CFR 1271.200(e)Documentation of maintenance and cleaning