FDA inspection

AGC Biologics A/S: FDA inspection ending Jun 29, 2023

FDA inspection 1316666 · Voluntary Action Indicated (VAI) · Soborg

Key facts

Inspection ID 1316666
Firm AGC Biologics A/S
FEI number 3004708748
Address Vandtarnsvej 83b
City Soborg
Country Denmark
Fiscal year 2023
Inspection end date Jun 29, 2023
Classification Voluntary Action Indicated (VAI)
Project area Drug Quality Assurance
Product type Drugs

At a glance

  • None Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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