GLPGCP Development (Asia) Pte. Ltd.May 18, 2017

FDA 483 - GLPGCP Development (Asia) Pte. Ltd. - May 18, 2017

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Record Details

An FDA inspection of Ningbo Hecai Medical Equipment Co. Ltd., a medical device manufacturer in Ningbo Zhejiang, China, identified a significant quality system deficiency. The inspection revealed that the firm's procedures for corrective and preventative actions were not adequately established. This finding indicates a fundamental issue in the firm's quality management system.

Company: GLPGCP Development (Asia) Pte. Ltd.
Inspection Date: May 18, 2017
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Akbar J. Zaidi

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ID · 3a0a3c58-fa17-4496-9fd8-425c92f62a60