483
Nipro (Thailand) Corporation LimitedNipro (Thailand) Corporation Limited – FDA 483, May 3, 2018
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.
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ID · 678ad3c4-9c09-455b-baa1-b59e998d1e27
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