FDA strengthens process of initiating voluntary recalls

The US Food and Drug Administration (FDA) has issued a new draft guidance to provide industry with information on ways to prepare, plan and work with the agency to ensure voluntary recalls are initiated properly and promptly.

This draft guidance, Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C, includes recommendations in three key areas, namely training, record keeping and procedures.

The training guidance surrounds the readying of staff for potential recall situations, while the instruction on record keeping is stressed as especially important given the FDA’s efforts to improve recalls through product traceability by tapping into modern approaches such as blockchain technology, and advises companies on the importance of properly coding products and maintaining distribution records in order to conduct the most effective recall possible.