FDA 483 - GLPGCP Development (Asia) Pte. Ltd. - May 18, 2026

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.