The US Food and Drug Administration (FDA) has issued a draft guidance document titled ‘Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C’, which states that it is critical for manufacturers of FDA-regulated products to be ‘recall ready’ should there be a need to instigate a voluntary recall.
The draft, copy available from here, was released together with a statement from FDA Associate Commissioner for Regulatory Affairs, Melinda Plaisier, in which she explains that “For a recall to be effective and timely, it’s crucial that companies be prepared in advance to take all necessary steps for when a recall is initiated”. When finalized, she continued, the guidance will “provide industry with clear information on ways to prepare, plan and work with the FDA to ensure voluntary recalls are initiated properly and promptly.”
The draft guidance suggests manufacturers should prepare for a recall by taking specific steps, including identifying appropriate personnel to handle recall-related responsibilities, and identifyingalternate employees who can stand in if needed. In addition, the draft suggests companies should establish a recall team if it anticipates that its recall efforts would be complex or have other complicating factors, such as having a large or multilayered distribution chain.
“Proper training of personnel is perhaps one of the most important elements to effectively executing a recall”, Plaisier continues in her statement.