FDA 483 - Spectrum Pharmaceuticals, Inc. - May 27, 2016

Spectrum Pharmaceuticals Inc. in Irvine, CA, was cited for significant deficiencies in its clinical trial monitoring processes. The inspection revealed failures to properly report protocol deviations in submitted NDA data listings and delays in drafting and submitting monitoring reports. Additionally, the firm did not promptly address and document non-compliance by investigators, lacking evidence of corrective actions or a developed plan.