Ann: FDA Schedules GvHD Pre-License Manufacturing Inspection, page-65

Mock inspection affirmed BLA-submission readiness at manufacturing site

LONZA has passed multiple PLI's, they won't need 60 days notice.

A. Pre-License Inspection – Inspection of a facility (new or existing) that will
be used to manufacture a new biological product (i.e., inspection for a new
Biologics License Application). This includes inspections of
establishments that already manufacture other currently approved
products

22. Ensure that decisions regarding the need for pre-license or pre-approval facility
inspections (refer to SOPP 8410: Determining When Pre-License/Pre-Approval
Inspections are Necessary) and/or Bioresearch Monitoring (BIMO) clinical site inspections
are made as soon as possible.
Note: If a BLA Pre-License or NDA Pre-Approval inspection is deemed necessary,
FDA’s goal is to communicate its intent to inspect a manufacturing facility at least 60
days in advance of the inspection and no later than mid-cycle. However, in accordance
with the PDUFA VII commitment letter, FDA reserves the right to conduct manufacturing
facility inspections at any time during the review cycle, whether or not FDA has
communicated to the facility the intent to inspect.