Koo Medical Equipment (Shanghai) Co., Ltd., Shanghai, China – FDA Inspections

Inspection records and compliance data for Koo Medical Equipment (Shanghai) Co., Ltd. in Shanghai. 2 FDA inspections on record, last inspected September 12, 2013.

Company Profile

This profile covers Koo Medical Equipment (Shanghai) Co., Ltd. based in Shanghai, China.

FDA Inspection History

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

First inspected October 26, 2011. Last inspected September 12, 2013.

Most cited issue areas

Production processes1 inspection

FDA inspections (2)

Date	Result	FDA center(s)	Insp. #
September 12, 2013	VAI	Medical Devices & Rad Health · Compliance: Devices	850439
October 26, 2011	NAI	Medical Devices & Rad Health · Compliance: Devices	753820

FDA documents

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

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