Fda form 3486-2026

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4.9 out of 5

47 votes

The document is a Biological Product Deviation Report form used by the FDA to collect information regarding deviations in biological products. It includes sections for facility information, details about the deviation, contributing factors, product information, and follow-up actions. The report is required under specific CFR regulations and outlines the process for submission to the appropriate FDA offices.

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Click ‘Get Form’ to open FDA Form 3486 in the editor.
Begin by filling out Section A, which includes your facility information. Ensure you provide the establishment name, address, and contact details accurately.
Move to Section B for Biological Product Deviation (BPD) Information. Here, input the establishment tracking number, dates of occurrence, discovery, and reporting of the BPD. Use Page 2 for detailed descriptions.
In Section C, specify the type of product involved—Blood or Non-Blood. Fill in the total number of units or lots and their respective details such as expiration dates and product codes.
Finally, review all sections for completeness and accuracy before submitting your form through our platform.

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Versions	Form popularity	Fillable & printable
2017	4.4 Satisfied (47 Votes)
2012	4.9 Satisfied (47 Votes)

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3486

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