FDA inspection

Patheon Austria GmbH & Co. KG: FDA inspection ending Nov 30, 2018

FDA inspection 1098613 · Voluntary Action Indicated (VAI) · Linz

Key facts

Inspection ID 1098613
Firm Patheon Austria GmbH & Co. KG
FEI number 3002806853
Address Sankt-Peter-Strase 25
City Linz
Country Austria
Fiscal year 2019
Inspection end date Nov 30, 2018
Classification Voluntary Action Indicated (VAI)
Project area Drug Quality Assurance
Product type 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
  • 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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