date:Jun 05, 2012
Currently, providing information in response to the new data elements is voluntary. However, responses to these elements will become mandatory later in 2012, FDA said. The additional elements are:
The reason the food has been determined to be reportable (agent);
A description of the root cause of the reportable food (if applicable);
A brief justification of the process used to determine which product(s), lot(s), or batch(es) were affected;
Whether or not the submitter believes all of the re