From October 28 to 31, 2013, FDA made a 4-day site inspection on the 9 registered APIs of Carelife under Yao Pharma.

During thorough inspection of warehouse, QC, manufacturing workshop, equipment, air-conditioning, purified water system and documentation, the inspectors paid high attention to the overall quality system and put forward many valuable suggestions and eventually announced Carelife passed the inspection with zero defect.

It is reported that it is the 4th site inspection of FDA since Changshou Site received FDA audit in 2007. It means not only another assessment of Carelife’s new version of GMP, but the permit renewal for access of APIs to U.S. market, which will greatly drive our international sales in the fierce international pharmaceutical competition.