Intelligent System Co., Ltd.May 18, 2023

FDA 483 - Intelligent System Co., Ltd. - May 18, 2023

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Record Details

Intelligent System Co., Ltd. in Nanto, Japan, a medical device specification developer, received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning the lack of adequate written procedures. These issues relate to device servicing, complaint handling, and Medical Device Reporting (MDR).

Company: Intelligent System Co., Ltd.
Inspection Date: May 18, 2023
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Maryam Tabatabaie (issuing_officer)

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ID · 31fd1c68-cb50-4657-8c51-ce8e4030db50