Alere (Shanghai) Diagnostics Co., Ltd., Shanghai, China – FDA Inspections

Inspection records and compliance data for Alere (Shanghai) Diagnostics Co., Ltd. in Shanghai. 3 FDA inspections on record, last inspected February 25, 2016.

Company Profile

This profile covers Alere (Shanghai) Diagnostics Co., Ltd. based in Shanghai, China.

FDA Inspection History

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

First inspected December 2, 2010. Last inspected February 25, 2016.

Most cited issue areas

Info evaluated to determine if event was reportable1 inspection
Lack of or inadequate complaint procedures1 inspection
Lack of or inadequate procedures1 inspection

FDA inspections (3)

Date	Result	FDA center(s)	Insp. #
February 25, 2016	NAI	Medical Devices & Rad Health · Compliance: Devices	961594
March 14, 2013	NAI	Medical Devices & Rad Health · Compliance: Devices	824468
December 2, 2010	VAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	706893

FDA documents

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

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