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Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing
ICR 202301-0910-014
OMB: 0910-0458
Federal Form Document
OMB.report
HHS/FDA
OMB 0910-0458
ICR 202301-0910-014
( )
Forms and Documents
Document
Name
Status
Form FDA 3486A Form FDA 3486A; Web-based Addendum
Form
Modified
Form FDA 3486 HCT/P deviations
Form and Instruction
Modified
Form FDA 3486 Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services
Form and Instruction
Modified
0458 Deviation Reports SSA 2023.docx
Supporting Statement A
2023-01-24
IC Document Collections
IC ID
Document
Title
Status
6151
Reporting of Biological Product Deviations by Licensed Manufacturer
Other-IT Landing Page Screenshot
Modified
178972
Form FDA 3486A; Web-based Addendum
Form
Modified
178971
HCT/P deviations
Form and Instruction
Modified
178970
Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services
Form and Instruction
Modified
ICR Details
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