Assure Tech (Hangzhou) Co., Ltd, Hangzhou, China – FDA Inspections

Inspection records and compliance data for Assure Tech (Hangzhou) Co., Ltd in Hangzhou. 2 FDA inspections on record, last inspected March 27, 2018.

Company Profile

This profile covers Assure Tech (Hangzhou) Co., Ltd based in Hangzhou, China.

FDA Inspection History

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

First inspected November 21, 2014. Last inspected March 27, 2018.

Most cited issue areas

DMR - not or inadequately maintained1 inspection
Investigation of device failures1 inspection
Lack of or inadequate receiving acceptance procedures1 inspection

FDA inspections (2)

Date	Result	FDA center(s)	Insp. #
March 27, 2018	Not classified	Medical Devices & Rad Health	1078065
November 21, 2014	VAI	Medical Devices & Rad Health · Compliance: Devices	906649

FDA documents

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

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