In a new draft guidance, “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” there are recommendations in three key areas: training, recordkeeping and procedures.
Proper training is an important element to effectively executing a recall. The draft guidance advises companies on ways to best identify and train appropriate personnel on their responsibilities during a recall, establish a recall communications plan, and identify what FDA reporting requirements there may be, among other things.