FDA inspection

Sirtex Singapore Manufacturing Pte Ltd: FDA inspection ending May 31, 2012

FDA inspection 786426 · No Action Indicated (NAI) · Singapore

Key facts

Inspection ID 786426
Firm Sirtex Singapore Manufacturing Pte Ltd
FEI number 3009088444
Address 50 Science Park Road, The Kendall
City Singapore
Fiscal year 2012
Inspection end date May 31, 2012
Classification No Action Indicated (NAI)
Project area Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: 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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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