Neusoft Medical Systems Co., Ltd., Shenyang, China – FDA Inspections

Inspection records and compliance data for Neusoft Medical Systems Co., Ltd. in Shenyang. 5 FDA inspections on record, last inspected January 24, 2019.

Company Profile

This profile covers Neusoft Medical Systems Co., Ltd. based in Shenyang, China.

FDA Inspection History

FDA inspections: 5
OAI: 0
VAI: 3
NAI: 2
Form 483s: 0
Warning letters: 0

First inspected June 3, 2010. Last inspected January 24, 2019.

Most cited issue areas

Compliance measurements--diagnostic source assembly1 inspection
Failure to report1 inspection
Incorrect translation to production specifications1 inspection

FDA inspections (5)

Date	Result	FDA center(s)	Insp. #
January 24, 2019	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	1083050
February 4, 2016	VAI	Medical Devices & Rad Health · Compliance: Devices	957496
January 29, 2016	VAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	957490
August 2, 2013	NAI	Medical Devices & Rad Health · Compliance: Devices	844103
June 3, 2010	VAI	Medical Devices & Rad Health · Compliance: Devices	667977

FDA documents

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

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