Get Form Fda 3486

Filling out the Form FDA 3486 online can help streamline the process for reporting biological product deviations. This guide offers clear, step-by-step instructions to assist users in completing the form accurately and efficiently.

Follow the steps to complete the Form FDA 3486 online

1. Press the ‘Get Form’ button to access the form and open it in the online editor.
2. Fill out section A, which includes your facility information. Ensure all required fields marked with an asterisk (*) are completed, including the facility name, street address, city, state, zip code, and point of contact.
3. In section B, provide detailed information about the biological product deviation. Record key dates, including when the deviation occurred, was discovered, and was reported. Describe the deviation clearly and include any contributing factors or root causes.
4. If the deviation occurred at a different facility, complete the appropriate section, providing the establishment’s name, address, and identification number as necessary.
5. In section C, specify the type of product involved in the deviation, whether it is blood or non-blood. Enter details such as collection or expiration dates, product codes, and disposition for each item.
6. Use the additional comments section to provide any extra information relevant to the report.
7. Review all entries for accuracy and completeness. Once confirmed, you can save your changes, download a copy, print it for your records, or share the form as needed.

Complete your documents online efficiently and accurately.