This information collection supports agency regulations regarding the reporting of biological product deviations and human cells, tissues, and cellular and tissue-based product deviations. Respondents to the collection are manufacturers of these products. The information collection supports the agency's mission to protect the public health by safeguarding against the transmission and spread of communicable disease.
The latest form for Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing expires 2023-01-31 and can be found here.
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Form |
Form and Instruction |
Form and Instruction |
Supporting Statement A |
Federal Enterprise Architecture: Health - Consumer Health and Safety
Form FDA 3486 | Biological Product Deviation Report | www.fda.gov/vaccines-blood-biologics/report-problem-center-biologics-evaluation-research/biological-product-deviations | Form and instruction |
Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.