Flexicare Medical (Dongguan) Ltd., Dongguan, China – FDA Inspections

Inspection records and compliance data for Flexicare Medical (Dongguan) Ltd. in Dongguan. 3 FDA inspections on record (1 OAI), last inspected March 21, 2024.

Company Profile

This profile covers Flexicare Medical (Dongguan) Ltd. based in Dongguan, China.

FDA Inspection History

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

First inspected August 26, 2010. Last inspected March 21, 2024.

Most cited issue areas

Product rework documentation, DHR {see also 820.184}2 inspections
Documentation1 inspection
Documentation of validated process performance1 inspection

FDA inspections (3)

Date	Result	FDA center(s)	Insp. #
March 21, 2024	VAI	Medical Devices & Rad Health · Compliance: Devices	1235507
January 24, 2013	NAI	Medical Devices & Rad Health · Compliance: Devices	816936
August 26, 2010	OAI	Medical Devices & Rad Health · Compliance: Devices	682638

FDA documents

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

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