Starkey (Suzhou) Hearing Technology Co., Ltd., Suzhou, China – FDA Inspections

Inspection records and compliance data for Starkey (Suzhou) Hearing Technology Co., Ltd. in Suzhou. 3 FDA inspections on record, 1 Form 483, last inspected September 25, 2025.

Company Profile

This profile covers Starkey (Suzhou) Hearing Technology Co., Ltd. based in Suzhou, China.

FDA Inspection History

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

First inspected April 11, 2014. Last inspected September 25, 2025.

FDA inspections (3)

Date	Result	FDA center(s)	Insp. #
September 25, 2025	Not classified	Medical Devices & Rad Health	1287426
September 15, 2017	Not classified	Medical Devices & Rad Health	1031439
April 11, 2014	NAI	Medical Devices & Rad Health · Compliance: Devices	875263

FDA documents

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

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