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FDA Inspection 1265749 — AGC Biologics, Inc.

AGC Biologics, Inc. — FEI 3000209996

The FDA completed an inspection of AGC Biologics, Inc. on April 18, 2025 in Bothell, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 18, 2025
Fiscal Year
2025
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Bothell, WA (United States)

Facility

Other inspections at this facility

  • 1197098 (VAI Fri Feb 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1149254 (VAI Fri Jul 23 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1109813 (VAI Mon Oct 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 930335 (NAI Fri May 15 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 779103 (NAI Wed Apr 18 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources