FDA requires that all adverse and serious adverse events are tracked and reported, as required. Adverse event reporting is key area that inspectors focus on when inspecting a company.

Tracking and reporting adverse events is required by law and the FDA has the right to request access to all of your product complaints, as required under 21 CFR part 111.570, during an inspection. The product complaint forms should show all adverse events and serious adverse events which should have been reported to the FDA. Any serious adverse event should be reported to the FDA within 15 days of receiving the complaint. The FDA has issued Warning letters based on incidents where FDA inspectors have found serious adverse events detailed in product complaint forms that have not been reported to the FDA.

What is an adverse event?

A common problem found is that many do not understand what the requirements would be for an adverse event to be considered a serious adverse event. An adverse event is “any health-related event associated with the use of a dietary supplement that is adverse. “A serious adverse event is an adverse event that results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect; or requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described above¹.

Inspections continue to focus on adverse event reporting

FDA has also been continuously increasing the number of inspections they plant to conduct each year with 341 inspections conducted in 2012. This number is expected to be even higher for 2013. Adverse event reporting and serious adverse event reporting will be a key area of focus in upcoming inspections and all manufactures should be ready to show records of their adverse event reporting and serious adverse event reporting to the FDA inspectors. Furthermore, it is of utmost importance that you are able to provide evidence that that all serious adverse events have been reported to the FDA. Take note that the responsible person for reporting a serious adverse event report to the FDA according to The Dietary Supplement and Non-prescription Drug Consumer Protection Act is the manufacturer, packer, or distributor whose name appears on the label of a dietary supplement marketed in the United States.

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References:

1. http://www.fda.gov/safety/medwatch/howtoreport/ucm053087.htm