Spectrum Pharmaceuticals, Inc.February 12, 2020

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

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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.

Company: Spectrum Pharmaceuticals, Inc.
Inspection Date: February 12, 2020
Product Type: Drugs
Office: Division of Pharmaceutical Quality Operations IV
People: Lavender M Huskey
Angela Shepas (investigator)

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ID · 3ae6deb6-ea4b-41f4-9fe6-c56a8fb1ece1