Fudakang Industrial Co Ltd, Dongguan, China – FDA Inspections

Inspection records and compliance data for Fudakang Industrial Co Ltd in Dongguan. 4 FDA inspections on record, 2 Form 483s, last inspected March 12, 2026.

Company Profile

This profile covers Fudakang Industrial Co Ltd based in Dongguan, China.

FDA Inspection History

FDA inspections: 4
OAI: 0
VAI: 0
NAI: 2
Unclassified: 2
Form 483s: 2
Warning letters: 0

First inspected August 7, 2014. Last inspected March 12, 2026.

Most cited issue areas

Changes to the QMS not adequately controlled or evaluated1 inspection
Individual Report of Malfunction1 inspection
Records of nonconforming product and actions taken not maintained1 inspection

FDA inspections (4)

Date	Result	FDA center(s)	Insp. #
March 12, 2026	Not classified	Medical Devices & Rad Health · Compliance: Medical Devices	1311204
October 19, 2023	NAI	Medical Devices & Rad Health · Compliance: Devices	1223751
March 17, 2017	Not classified	Medical Devices & Rad Health	1007166
August 7, 2014	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	890431

FDA documents

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

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