There are a total of 14 observations. However, only 22% may take longer time to complete the rectify actions as they require the validation from third parties. Others can be mostly rectified immediately without too much effort. We are committed to have them rectified within three weeks ( 15 working days). 

Following the renewal of ISO 13485 and Korean FDA's audit in 2015, the completion of US FDA inspection is a new milestone to Coreleader during last nine years. Such endorsement would allow Coreleader embrace US market fully as US patient now may have full confidence on Coreleader's quality commitment which we tolerate no slack. It also proves that we walk to talk.