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

Inspection records and compliance data for Amsino Medical (Kunshan) Co., Ltd. in Suzhou. 4 FDA inspections on record, last inspected June 14, 2018.

Company Profile

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

FDA Inspection History

FDA inspections: 4
OAI: 0
VAI: 1
NAI: 3
Form 483s: 0
Warning letters: 0

First inspected November 4, 2010. Last inspected June 14, 2018.

Most cited issue areas

Lack of or inadequate procedures for storage.1 inspection

FDA inspections (4)

Date	Result	FDA center(s)	Insp. #
June 14, 2018	NAI	Medical Devices & Rad Health · Compliance: Devices	1059046
May 12, 2016	NAI	Medical Devices & Rad Health · Compliance: Devices	975320
September 12, 2013	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	852513
November 4, 2010	VAI	Medical Devices & Rad Health · Compliance: Devices	708717

FDA documents

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

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