FDA inspection

GlaxoSmithKline Biologicals Kft.: FDA inspection ending Oct 6, 2015

FDA inspection 947992 · Voluntary Action Indicated (VAI) · Godollo

Key facts

Inspection ID 947992
Firm GlaxoSmithKline Biologicals Kft.
FEI number 3008322822
Address Homoki Nagy Istvan utca 1
City Godollo
Country Hungary
Fiscal year 2016
Inspection end date Oct 6, 2015
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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