I corrected myself too soon....
"notify the applicant of our intent to inspect the manufacturing facility at least 60 days in advance of the inspection"
They notified MSB a long time ago that they intended to inspect the facility if and when we resubmitted the BLA.
As long as the "intent to inspect" notification happened at least 60 days in advance, MSB and FDA could agree to schedule the actual inspection at any time..
Ann: FDA Schedules GvHD Pre-License Manufacturing Inspection, page-71
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