BCM Co., Ltd. – FDA Inspection, Sep 18, 2025

Record Details

This FDA Inspection record concerns BCM Co., Ltd., with an inspection on September 18, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: BCM Co., Ltd.
Inspection Date: September 18, 2025
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Kwong P. Lee (Company Rep)

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ID · 8e3624e4-00fc-439d-b5c4-cf3ed419e4ca

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number: 1282002
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Medical Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.30(g)Design validation - simulated testing
21 CFR 820.198(a)Complaints
21 CFR 820.184DHR - not or inadequately maintained

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FDA Inspection

BCM Co., Ltd.September 18, 2025