In my 44 years in the industry, I don’t think any issue has raised as many questions, caused companies to scratch their heads or raised the level of angst more than the issue of the dreaded Field Alert Report (FAR).  Well now – and finally – the FDA has issued a Q&A document that answers many of those head- scratching questions.

The draft document, entitled Field Alert Report Submission Questions and Answers Guidance for Industry (here)  provide 31 individual responses to questions from the 6 different general categories listed below:

  1. What is a FAR and what triggers its submission?
  2. Who is responsible for submitting the FAR?
  3. When should I submit a FAR?
  4. How do I submit a FAR?
  5. Where do I submit a FAR?
  6. Should I submit a follow-up or final FAR?

The FDA responses cover lots of ground as they tackle many of the areas that have caused industry concern.  For instance, did you know that follow-up and final FARs are not required but it is FDA’s expectations that they will be submitted (see FDA response to 1.b).  The FDA notes that if multiple customer complaints are received, a FAR for each does not have to be submitted if the complaint covers the same issue with product from the same lot(s) identified in the original FAR.

Also of interest is a question as to whether a FAR must be issued for an OOS result or a problem with a lot that has not yet been distributed – the Agency’s answer is NO, if it does not impact other lots in distribution (they note that a FAR is for distributed products only).  Another asks if an OOS result occurs on a distributed batch but the OOS is invalidated within three business days, is a FAR required to be submitted? FDA response, No!  However, another question asks if a corrective action is taken within three business days and the problem is fixed does a FAR need to be submitted – FDA response – Yes!  A little bit of a different situation but an important distinction to make.  Another good one was if a problem involves multiple NDAs or ANDAs, does a separate FAR need to be submitted.  FDA answers Yes, a separate FAR must be submitted to each application.

There are lots of good reading in this draft document.  Please make certain you digest it all before you have a problem or indigestion might not be FAR away.