Infus Medical Co., Ltd., Amphoe Muang Khon Kaen, Thailand – FDA Inspections

Inspection records and compliance data for Infus Medical Co., Ltd. in Amphoe Muang Khon Kaen. 2 FDA inspections on record, 1 Form 483, last inspected June 12, 2025.

Company Profile

This profile covers Infus Medical Co., Ltd. based in Amphoe Muang Khon Kaen, Thailand.

FDA Inspection History

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

First inspected January 26, 2017. Last inspected June 12, 2025.

Most cited issue areas

Investigation of device failures1 inspection
Lack of or inadequate process validation1 inspection

FDA inspections (2)

Date	Result	FDA center(s)	Insp. #
June 12, 2025	VAI	Medical Devices & Rad Health · Compliance: Medical Devices	1274830
January 26, 2017	NAI	Medical Devices & Rad Health · Compliance: Devices	1004672

FDA documents

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

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