FDA District Offices Expect Specific Information From Firms When Recalls Are Initiated

By Shawn M. Schmitt / Email the Author / “The Silver Sheet” January 2012, Vol. 16, No. 1
Word Count: 1533 / Article # 09120111005

Executive Summary

Before initiating a recall, firms should first contact an FDA district office so it can review recall communications and strategies. “The district office may look at your recall strategy and find that somehow it’s inadequate, so the agency may push for you to amend it,” said Cecilia Wolyniak, an FDA recall team leader. Officials explain the types of information that should be sent to district offices.