MIRAE MEDI&TECH CO., LTD. – FDA Inspection, Apr 26, 2018

Record Details

This FDA Inspection record concerns MIRAE MEDI&TECH CO., LTD., with an inspection on April 26, 2018, issued by the Center for Devices and Radiological Health, covering devices.

Company: MIRAE MEDI&TECH CO., LTD.
Inspection Date: April 26, 2018
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Kwong P. Lee (Company Rep)

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ID · cde27cc9-daa8-4d33-b86a-7d02e693dc7a

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1053525
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.184DHR - not or inadequately maintained
21 CFR 820.75(a)Documentation
21 CFR 820.40(b)Document change records, maintained.

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FDA Inspection

MIRAE MEDI&TECH CO., LTD.April 26, 2018