Submitting Field Alert Reports (FARs) to CBER

The purpose of field alert reports (FARs) is to quickly identify drug products in distribution that pose potential safety threats. Within 3 days of discovering significant problems with distributed drug product, holders of approved new drug applications (NDAs) or abbreviated new drug applications (ANDAs) must submit a FAR to FDA to comply with 21 CFR 314.81(b)(1).

What must be reported?

Information concerning one or more of the following:

• Incidents that cause the drug product or its labeling to be mistaken for or applied to another article;
• Bacterial contamination;
• Any significant chemical, physical, or other change or deterioration in the distributed drug product;
• Any failure of one or more distributed batches of the drug product to meet the specifications established in its application.

How do I submit a FAR?

Submit Form FDA 3331a to the FDA district office that is responsible for the facility involved; contact information is provided in the form. Links to the form, form instructions, questions and answers, and related resources (e.g., applicable regulations) are found below. You can use Form FDA 3331a to submit FARs for CDER or CBER regulated drug products that are approved under an NDA or ANDA.

Form and Instructions

• Form FDA 3331a and Form FDA 3331a Instruction

Frequently Asked Questions

• Field Alert Report Form: Questions and Answers

Related Resources

• Notice to Industry: With End of Pilot Project, FDA Introduces Updated Form To Submit FARs Electronically
• FAR regulations for NDAs
• FAR regulations for ANDAs
• Office of Compliance and Biologics Quality (OCBQ)
• CBER/Office of Compliance and Biologics Quality (OCBQ)/Division of Inspections and Surveillance (DIS)
• Biological Product Deviations
• Report a Problem to CBER
• Report a Product Quality Issue to CDER
• Field Alert Reports- CDER