September 30, 2023 at 06:00PM General Instructions for Completing the Biological Product Deviation Report (BPDR) - Form FDA 3486

For use by biological product manufacturers to report biological product deviations (BPD) that may affect the safety, purity, or potency of a distributed product in accordance with 21 CFR, Part 600.14 or 606.171. Also for use by Human Cells, Tissues and Cellular and Tissue-Based Product (HCT/P) manu

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