Laerdal Medical (Suzhou) Co., Ltd., Suzhou, China – FDA Inspections

Inspection records and compliance data for Laerdal Medical (Suzhou) Co., Ltd. in Suzhou. 3 FDA inspections on record, last inspected November 03, 2016.

Company Profile

This profile covers Laerdal Medical (Suzhou) Co., Ltd. based in Suzhou, China.

FDA Inspection History

FDA inspections: 3
OAI: 0
VAI: 2
NAI: 1
Form 483s: 0
Warning letters: 0

First inspected April 28, 2010. Last inspected November 3, 2016.

Most cited issue areas

Documentation1 inspection
Lack of or inadequate procedures1 inspection
Lack of or inadequate procedures - Acceptance activities1 inspection

FDA inspections (3)

Date	Result	FDA center(s)	Insp. #
November 3, 2016	NAI	Medical Devices & Rad Health · Compliance: Devices	1029850
June 6, 2013	VAI	Medical Devices & Rad Health · Compliance: Devices	838796
April 28, 2010	VAI	Medical Devices & Rad Health · Compliance: Devices	660424

FDA documents

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

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