FDA Inspection 1203574 — AGC Biologics A/S

AGC Biologics A/S — FEI 3004708748

The FDA completed an inspection of AGC Biologics A/S on April 22, 2021 in Soborg. 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
April 22, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Soborg (Denmark)

Additional Details

Mutual Recognition Agreement (MRA)