Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Thinking about it further, I think it didn't have to do w what I initially posted

"What kind of major finding did they find that will stop the agency from accepting SPPIs CA on paper; is it control of API and other suppliers (excipients, etc); or data management, or facility/computer/equipment validation, HVAC, water systems, etc.

because if that was the case I would think they would have been able to propose corrective action that the agency could accept and thus no CRL. Maybe there is a problem w the complexity of actually making the product i.e. LAPS-GCSF Fc to the FcRn receptor. That would explain why other inspectors from other agencies such as the Korean FDA approved the facility.