Form FDA 3486 FDA 3486 Biological Product Deviation Report

Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing

FDA 3486 3-12-20 Secured

Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services

OMB: 0910-0458