United States FDA Publishes Draft Guidance on Recommendations to Voluntary Recalls

On April 24, 2019, the Food and Drug Administration (FDA) of the United States released the draft guidance titled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C.”

Recommendations are addressed to industry and Agency staff in order to achieve a timely initiation of voluntary recalls of food, drug and devices intended for human or animal use, and all other products subject to FDA’s jurisdiction.

The areas of discussion of the guidance are the following:

• Training: firms in a product distribution chain have to be “recall ready” by identifying and training appropriate personnel, establishing a recall communications plan, identifying any reporting requirements associated with products, using product coding and maintaining distribution records and recalls initiation procedures;
• Manage products problems: firms have to identify, investigate and report product problems when specific regulatory requirements are violated;
• Initiate recalls and reporting: firms must send recall communications timely to each affected direct account and must issue a public notice, if appropriate. FDA will cooperate and facilitate the removal of the product in the marketplace.

Read the full text of the press release here.