Get the free FORM FDA 3486

FDA USE ONLYDEPARTMENT OF HEALTH AND HUMAN SERVICESFOOD AND DRUG ADMINISTRATIONDate Received:BIOLOGICAL PRODUCT DEVIATION Reportage Reviewed: BPD ID: BPD No.* Indicates required information. FACILITY

How to fill out form fda 3486

How to fill out form fda 3486

1. To fill out form FDA 3486, follow these steps:
2. Start by entering the name and address of the manufacturer, packer, or distributor of the product.
3. Provide the FDA establishment registration number (if applicable).
4. Indicate the date the form is being completed.
5. Specify the name and contact information of the person responsible for submitting the report.
6. Describe the deviation or unexpected event that occurred with the product.
7. Provide information on the product, including its name, strength, dosage form, lot number, and expiration date.
8. Indicate whether the product was distributed or if it is still in the possession of the manufacturer.
9. Explain any actions taken to investigate or correct the issue.
10. Include any additional comments or details that may be relevant.
11. Sign and date the form.
12. Submit the completed form to the appropriate FDA district office.
13. Note: It is important to accurately and thoroughly fill out the form to ensure compliance and facilitate any necessary actions by the FDA.

Who needs form fda 3486?

1. Form FDA 3486 is needed by manufacturers, packers, and distributors of regulated products. It is used to report deviations or unexpected events associated with a product that may impact its safety, effectiveness, or quality. The form helps the FDA monitor and address potential issues, ensuring the protection of public health.

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What is form fda 3486?

Form FDA 3486 is a document used by the Food and Drug Administration (FDA) for the registration and listing of facilities that manufacture, process, pack, or hold human and animal food.

Who is required to file form fda 3486?

Facilities that are engaged in the manufacturing, processing, packing, or holding of human and animal food are required to file Form FDA 3486.

How to fill out form fda 3486?

To fill out Form FDA 3486, one must provide identifying information about the facility, contact details, type of activities performed, and submit any supporting documentation as required by the FDA.

What is the purpose of form fda 3486?

The purpose of Form FDA 3486 is to help the FDA maintain an updated registry of food facilities and ensure compliance with food safety regulations.

What information must be reported on form fda 3486?

Information that must be reported on Form FDA 3486 includes the name and address of the facility, contact information, type of business, and the products being processed or handled.