I believe the inspections (if there are to be any) will have already been done. The FDA's pre-approval inspection operations were disrupted due to Covid-19 but they have in pubic statemente emphasised that:
"Breakthrough therapies and regenerative medicine advanced therapies may gain approval even without a desired inspection. This policy also applies to other “mission critical” therapies used to diagnose, treat or prevent a serious disease where no treatment alternative is available."
I believe we are likely to have already worked through the pre-approval inspection process well before now.
For more detail see link here.
I believe the inspections (if there are to be any) will have...
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