FDA inspections are generally conducted on a product by product basis. If the sponsor has another product looking close to approval, they will generally request that the agency inspect that process as well, but this is not often granted. Note that these two manufacturing processes are quite different.
On the positive side, the second inspection will be simpler, given most of the physical infrastructure and systems such as QC will have already been covered.
Ann: Update on BLA for Graft Versus Host Disease, page-972
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