FDA ODAC Meeting Material discussion analysis, page-363

I'm familiar with Lonza and have inspected several of their cell therapy facilities, including their Tuas (Singapore) facility, so well aware of their GMP status and their clients!

Most of their biologic manufacture has been around mammalian cell culture which occupies different facilities to their cell therapy production.

AFAIK, none of their cell therapy facilities have been FDA approved for therapeutic use (Walkersville may be an exception, last time I looked Tuas cell therapy was not) - and this is not unusual, FDA will normally only request an inspection after the product is approved (some cases may be pre-approval, eg foreign facility which is being inspected for another product, they may piggyback inspection to save cost/time).