FDA 483 - Spectrum Pharmaceuticals, Inc. - February 12, 2020

An FDA inspection of Spectrum Pharmaceuticals Inc. in Irvine, CA, revealed that the firm failed to promptly bring noncompliant investigators into compliance during clinical studies SPI-GCF-301 and SPI-GCF-302. This included numerous protocol deviations, missed study procedures, and significant delays in completing electronic case report forms (eCRFs). This issue was a repeat observation from a previous inspection.