Access flooding information on Disaster Resources.

March 3, 2022

FDA Guidance on Preparing for Voluntary Recalls Now Available

The U.S. Food and Drug Administration has developed a guidance document to help companies prepare to quickly and effectively remove violative products from the market. The final guidance, Initiation of Voluntary Recalls Under 21 CFR Part 7 – Subpart C, can be downloaded here.

The guidance outlines the steps companies should take to develop recall policies and procedures before a recall is necessary. This includes training, planning and record-keeping to reduce the time a recalled product is on the market and, thus, limit the public’s exposure to risk. Additionally, it explains how companies should have adequate product coding and maintain distribution records to facilitate faster, more accurate recall actions.

For more information about the guidance, read FDA’s press release here.