XuZhou Kernel Medical Instrument Equipment Co. Ltd, Xuzhou, China – FDA Inspections

Inspection records and compliance data for XuZhou Kernel Medical Instrument Equipment Co. Ltd in Xuzhou. 2 FDA inspections on record, last inspected June 05, 2025.

Company Profile

This profile covers XuZhou Kernel Medical Instrument Equipment Co. Ltd based in Xuzhou, China.

FDA Inspection History

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

First inspected November 12, 2015. Last inspected June 5, 2025.

Most cited issue areas

DMR - not or inadequately maintained1 inspection

FDA inspections (2)

Date	Result	FDA center(s)	Insp. #
June 5, 2025	NAI	Medical Devices & Rad Health · Compliance: Devices	1275010
November 12, 2015	VAI	Medical Devices & Rad Health · Compliance: Devices	955604

FDA documents

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

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