Fair questions but the old working cell bank (WCB) was past its expiration date and a new cell bank is being “qualified.
I took the 483 to state that the existing working sell bank had been qualified to be viable until late 2022 per protocol but had become suspect of failure already.
I would think either their testing protocol is deficient or the WCB was damaged or contaminated. Revance didn't have a answer to these problems.