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Determining When Pre-License / Pre-Approval Inspections are Necessary SOPP 8410 Appendix 1
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Company

CONCUR / /

Facility

Facility Information / /

IndustryTerm

contract manufacturer / manufacturing change / /

Organization

HFM-670 office of Compliance and Biologics Quality / BLA Committee / /

Position

director of applications division / branch chief/supervisor / DATE Director / Division of Manufacturing and Product Quality / Chair / branch chief / DATE Director / Division / /