DONGGUAN BAO KANG DIAN ZI KE JI LIMITED, Dongguan, China – FDA Inspections

Inspection records and compliance data for DONGGUAN BAO KANG DIAN ZI KE JI LIMITED in Dongguan. 2 FDA inspections on record, 1 Form 483, last inspected June 08, 2017.

Company Profile

This profile covers DONGGUAN BAO KANG DIAN ZI KE JI LIMITED based in Dongguan, China.

FDA Inspection History

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

First inspected April 24, 2014. Last inspected June 8, 2017.

Most cited issue areas

DHR documentation of label release {see also 820.184}1 inspection

FDA inspections (2)

Date	Result	FDA center(s)	Insp. #
June 8, 2017	Not classified	Medical Devices & Rad Health · Compliance: Devices	1014689
April 24, 2014	NAI	Medical Devices & Rad Health · Compliance: Devices	879479

FDA documents

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

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