Field Alert Report (FAR)

In pharmaceutical industries timely file a FAR for marketed batch is very important. Many companies got USFDA observation (483) for not file FAR timely.

FAR required for any critical Market Complain, No Root Cause in 03 working days for any distributed product etc. 

A. What is a FAR?

FARs are part of an early warning system to protect patient health. As per $314.81(b)(1), you must submit a FAR for distributed drug products and articles to FDA if you receive information of the following kinds:

• Information  any incident that causes a drug product or its labeling to be mistaken for, or applied to, another article.
• Information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the distributed drug product, or any failure of 80 one or more distributed batches of the drug product to meet the specification established 81 for it in the application.

B. What is the required time frame for the submission of a FAR?

You must submit a FAR within 3 working days of receipt of the information described in  § 314.81(b)(1). We consider concerning days to be any day from Monday through Friday,  excluding U.S. Federal holidays. For example, if any information meeting the criteria requiring

 FAR is identified on Friday (day 0), then day 1 begins on the first working day after the information is identified (Monday), and you must submit the FAR by close of business on  Wednesday (day 3). This time frame applies regardless of where the information meeting the  criteria requiring a FAR is identified. For example, the day a contract lab learns of a sterility  failure is day 0, and you must submit the FAR by close of business on day 3.

C. Who is responsible for submitting the FAR?

As the NDA/ANDA applicant, you must submit the FAR. If you have a contractual agreement  with another person or entity to perform manufacturing, holding, packaging, labeling, or distribution activities or services for your products, you still hold ultimate responsibility for reporting FARs. You should establish, maintain, and follow a procedure for receiving and responding to any reportable information from contracted entities concerning your products