Ann: FDA Schedules GvHD Pre-License Manufacturing Inspection, page-112

I agree Dachopper , potency assay a big tick.
I went digging for Lonza/FDA relationships. This was Lonzas response to a failed inspection back in 2021. That's why the independent mock inspection pass and Lonzas recent cell or gene
approvals are so important.

“Lonza regularly receives visits from international regulatory bodies, including the FDA and in a typical year we host around ten FDA inspections,” Fowler wrote in an email. “We take compliance very seriously and do everything we can to ensure that all customers and stakeholders, including regulators, are satisfied. When issues come to our attention, we address them expeditiously and effectively, as is the case here.”

Tick box exercise forthcoming in Singapore.

Exciting times


Reg

shortly, Reg. Shortly!