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