Nipro (Thailand) Corporation LimitedMay 3, 2018

FDA 483 - Nipro (Thailand) Corporation Limited - May 03, 2018

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Record Details

An FDA inspection of Nipro (Thailand) Corporation Limited, a medical device manufacturer, revealed significant deficiencies in their quality system. Observations included inadequate documentation of design validation results, insufficient procedures for handling customer complaints, and failures in maintaining device history records. These issues indicate a need for improved record-keeping and complaint management practices.

Company: Nipro (Thailand) Corporation Limited
Inspection Date: May 3, 2018
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Kwong P. Lee (investigator)

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ID · 678ad3c4-9c09-455b-baa1-b59e998d1e27