FDA inspection

GlaxoSmithKline Biologicals: FDA inspection ending Jun 27, 2013

FDA inspection 846830 · Voluntary Action Indicated (VAI) · Dresden

Key facts

Inspection ID 846830
Firm GlaxoSmithKline Biologicals
FEI number 3004835618
Address Zirkusstr. 40
City Dresden
Fiscal year 2013
Inspection end date Jun 27, 2013
Classification Voluntary Action Indicated (VAI)
Project area Vaccine, Allergenic, and Live Biotherapeutic Products
Product type Biologics, 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
  • 10–99 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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