FDA inspection

GlaxoSmithKline Biologicals: FDA inspection ending May 19, 2015

FDA inspection 933296 · Voluntary Action Indicated (VAI) · Dresden

Key facts

Inspection ID 933296
Firm GlaxoSmithKline Biologicals
FEI number 3004835618
Address Zirkusstr. 40
City Dresden
Fiscal year 2015
Inspection end date May 19, 2015
Classification Voluntary Action Indicated (VAI)
Project area Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic 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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