Sirtex Singapore Manufacturing Pte Ltd, Singapore, Singapore – FDA Inspections

Inspection records and compliance data for Sirtex Singapore Manufacturing Pte Ltd in Singapore. 3 FDA inspections on record, last inspected October 03, 2018.

Company Profile

This profile covers Sirtex Singapore Manufacturing Pte Ltd based in Singapore, Singapore.

FDA Inspection History

FDA inspections: 3
OAI: 0
VAI: 1
NAI: 1
Unclassified: 1
Form 483s: 0
Warning letters: 0

First inspected May 31, 2012. Last inspected October 3, 2018.

Most cited issue areas

Lack of or inadequate procedures1 inspection
Not approved or obsolete document retrieval1 inspection

FDA inspections (3)

Date	Result	FDA center(s)	Insp. #
October 3, 2018	Not classified	Medical Devices & Rad Health	1122618
August 15, 2013	VAI	Medical Devices & Rad Health · Bioresearch Monitoring	845597
May 31, 2012	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	786426

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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