A new draft guidance published by FDA suggests steps that firms in a distribution chain, including manufacturers and distributors, should take to ensure they are prepared to timely identify and respond to product issues that might lead to a recall. The draft guidance, “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” focuses on three key areas to minimize delays: training for staff readiness, effective record keeping to ensure proper coding and distribution record maintenance, and maintaining well drafted procedures that dictate appropriate actions when a recall decision is made. The guidance also discusses how FDA assists firms with executing voluntary recalls.
Comments on the draft guidance will be accepted through June 24.
For additional information on recall readiness see our prior blog post.