The Food and Drug Administration has issued a new draft guidance intended to make it easier for industry in initiate voluntary recalls with the agency. “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” focuses on three key areas: training, record keeping, and procedures. The effort is being developed, said FDA, also to improve consumer access to life-saving information. According to a Stericycle recall report released in February, pharmaceutical and medical device recalls have increased considerably, mainly because of mislabeled products.
FDA says the new recommendations builds upon other expansions to the recall process that it has made over the 18 months, including alerts and advisories and new policies for posting recalls on the FDA’s Enforcement Report (web listing of recalls) faster.
The Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C includes:
Training: Proper training of personnel is perhaps one of the most important elements to effectively executing a recall. The draft guidance provides recommendations for companies who manufacture or distribute FDA-regulated products to adopt in readying their staff for potential recall situations. Specifically, this new draft guidance advises companies on ways to best identify and train appropriate personnel on their responsibilities during a recall, establish a recall communications plan, and identify what FDA reporting requirements there may be, among other things.
Record Keeping: Thorough and organized record-keeping is especially important as the agency continues its efforts to improve recalls through product traceability by tapping into modern approaches such as blockchain technology to further advance our mission of protecting public health. The draft guidance also advises companies on the importance of properly coding their products and maintaining distribution records in order to conduct the most effective recall possible.
Procedures: Written recall initiation procedures help to minimize delays created by uncertainty. For companies that initiate a recall, using initiation procedures can help reduce the amount of time a defective or potentially harmful product is on the market and that in turn reduces the potential exposure to consumers. For consignees of a company that initiates a recall, these procedures can help extend the recall quickly throughout the distribution chain. The guidance recommends that firms consider preparing and maintaining written recall initiation procedures to swiftly ensure their recalled products are removed from the market. These procedures should clearly describe the appropriate actions to take when a decision is made to initiate a recall. They should also help ensure that necessary actions are not overlooked and may minimize the disruptive effect a recall can have on a company’s operations.
