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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
Form FDA 3486 control no 0910 0458
Reporting of Biological Product Deviations by Licensed Manufacturer
OMB: 0910-0458
OMB.report
HHS/FDA
OMB 0910-0458
ICR 201911-0910-003
IC 6151
Form FDA 3486 FDA 3486 Biological Product Deviation Report
( )
⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0910-0458 can be found here:
2023-01-24 - Extension without change of a currently approved collection
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2020-01-10
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2019-11-05
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