FDA 483 - Hubei Gedian Humanwell Pharmaceutical Co., Ltd. - October 14, 2013

An FDA inspection of Hubei Gedian Humanwell Pharmaceutical Co., Ltd in Ezhou, China, revealed a significant quality system deficiency. The firm's Quality Unit failed to implement adequate controls to prevent adverse effects on API drug products during storage. Specifically, the monitoring system for critical parameters like temperature and humidity in the API warehouse lacked a backup system to ensure and confirm that deviations had not occurred and were fully investigated.