FDA Issues Draft Guidance to Improve Process for Voluntary Recalls

By Patricia Van Arnum - DCAT Editorial Director

May 2, 2019

The US Food and Drug Administration (FDA) has issued draft guidance, Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C, to specify new steps by the agency to strengthen the process of initiating voluntary recalls. The plan relates to three main areas: training, record-keeping, and procedures.

With respect to training, the draft guidance provides recommendations for companies who manufacture or distribute FDA-regulated products to adopt in readying their staff for potential recall situations. Specifically, the draft guidance advises companies on ways to best identify and train appropriate personnel on their responsibilities during a recall, establish a recall communications plan,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.

With respect to record-keeping, the draft guidance also advises companies on the importance of properly coding their products and maintaining distribution records in order to conduct the most effective recall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. The FDA said it continues its efforts to improve recalls through product traceability by tapping into modern approaches such as blockchain technology.

With respect to procedures, the draft guidance recommends that firms consider preparing and maintaining written recall initiation procedures to “swiftly” ensure their recalled products are removed from the market. This draft guidance specifies that the procedures should clearly describe the appropriate actions to take when a decision is made to initiate a recall. It also specifies that such procedures 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.

The agency says that the draft guidance builds upon 18 months of improvements to the FDA’s recall processes, during which the agency alerted companies of the situations where the FDA would disclose certain supply-chain and retail distribution information during certain human and animal food recalls; provided mandatory recall guidance for human and animal foods, which answered common questions about the mandatory food recall provisions; and issued final guidance on public warnings and notifications of recalls for all FDA-regulated products outlining specific circumstances in which the agency would expect a company to issue a public warning about a voluntary recall. The agency has also adopted new policies for moving forward with rapidly posting new recalls to the FDA’s Enforcement Report, which is a web listing of all recalls monitored by the FDA.

Source: FDA