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

⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0910-0458 can be found here:

Document [pdf]

Download: pdf | pdf