FDA inspection

Prothya Biosolutions Netherlands B.V.: FDA inspection ending Sep 28, 2011

FDA inspection 748170 · Official Action Indicated (OAI) · Amsterdam

Key facts

Inspection ID 748170
Firm Prothya Biosolutions Netherlands B.V.
FEI number 3007166802
Address Plesmanlaan 125
City Amsterdam
Country Netherlands
Fiscal year 2011
Inspection end date Sep 28, 2011
Classification Official Action Indicated (OAI)
Project area Blood and Blood Products
Product type Biologics

At a glance

  • None Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • Yes 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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