From October 28 to 31, 2013, US FDA conducted a 4-day site inspection on the 9 registered APIs of Carelife.

During thorough inspection of warehouse, QC, manufacturing workshop, equipment, HVAC system, purified water system and documentation system, the inspectors paid high attention to the overall quality system and provided many valuable suggestions. Eventually, Carelife passed the inspection with zero deficiency.

It is reported that this is the 4th site inspection of FDA since Changshou Site received FDA audit in 2007. It means not only an assessment of Carelife’s management after implementing the new version of GMP, but also a reassurance giving us access to the API market of US, which will greatly boost our international sales among the fierce international pharmaceutical competition.