FDA inspection

GlaxoSmithKline Biologicals: FDA inspection ending May 5, 2011

FDA inspection 730438 · Voluntary Action Indicated (VAI) · Dresden

Key facts

Inspection ID 730438
Firm GlaxoSmithKline Biologicals
FEI number 3004835618
Address Zirkusstr. 40
City Dresden
Fiscal year 2011
Inspection end date May 5, 2011
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 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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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