FDA 483 - Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd.

The FDA inspected Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd. in Changzhou, China, an API manufacturer. The inspection revealed significant deficiencies in control record management, specifically regarding logbook reconciliation and the lack of hard-bounded, numbered pages. Additionally, the firm's quality assurance unit failed to conduct comprehensive reviews of electronic data and audit trails for analytical results.