FDA inspection

Sirtex Germany Manufacturing GmbH: FDA inspection ending Mar 1, 2017

FDA inspection 1002984 · Frankfurt Am Main

Key facts

Inspection ID 1002984
Firm Sirtex Germany Manufacturing GmbH
FEI number 3013070673
Address Industriepark Hochst, Building G 808
City Frankfurt Am Main
Fiscal year 2017
Inspection end date Mar 1, 2017
Project area Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices
Product type Devices

At a glance

  • None Citations
  • None 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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