notice of premarket inspection from FDA Taimed announce she get the notice of premarket inspection from FDA on May 13.
It's so surprising the notice comes so soon, only 10 days after BLA filing.
The premarket inspection will be from July 19th to 27th, only 9 days to inspect the whole production cycle. It means Taimed had prepared and communicated with FDA sufficiently before BLA filing.
Sorry, Chinese version again:
https://m.cna.com.tw/news/afe/201705130270.aspx