FDA inspection

Kedrion S.p.A.: FDA inspection ending Sep 16, 2016

FDA inspection 990289 · Voluntary Action Indicated (VAI) · Gallicano

Key facts

Inspection ID 990289
Firm Kedrion S.p.A.
FEI number 3008919567
Address Via Provinciale
City Gallicano
Country Italy
Fiscal year 2016
Inspection end date Sep 16, 2016
Classification Voluntary Action Indicated (VAI)
Project area Vaccines and Allergenic Products
Product type Biologics

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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