FDA inspection

AGC Biologics SPA: FDA inspection ending Nov 20, 2023

FDA inspection 1232492 · Voluntary Action Indicated (VAI) · Bresso

Key facts

Inspection ID 1232492
Firm AGC Biologics SPA
FEI number 3020270660
Address Via Antonio Meucci 3
City Bresso
Fiscal year 2024
Inspection end date Nov 20, 2023
Classification Voluntary Action Indicated (VAI)
Project area Human Cellular, Tissue, and Gene Therapies
Product type Biologics, Drugs

At a glance

  • None Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • Yes 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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