FDA´s new Steps regarding Voluntary Recalls

Recommendation

5-7 November 2024
Hamburg, Germany

GMP meets Development
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

The U.S. Food and Drug Administration (FDA) has issued a new draft guidance on the initiation of voluntary recalls. The comment period ends on June 24, 2019.

The guideline includes recommendations in the following three key areas:

• Proper training of personnel: The draft guidance provides recommendations for companies to adopt in readying their staff for potential recall situations. Specifically, this new draft guidance advises companies on ways to best identify and train appropriate personnel in their responsibilities during a recall, establish a recall communications plan, and identify what FDA reporting requirements there may be.
• Thorough and organized record-keeping: This is especially important to improve recalls through product traceability by taking advantage of modern approaches such as blockchain technology. The draft guidance also advises companies on the importance of properly coding their products and maintaining distribution records in order to conduct the most effective recall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.
• Written recall initiation procedures: For companies that initiate a recall, using initiation procedures can help to reduce the amount of time a defective or potentially harmful product is on the market. "For consignees of a company that initiates a recall, these procedures can help extend the recall quickly throughout the distribution chain", the agency says. Therefore, the draft guidance recommends "that companies consider preparing and maintaining written recall initiation procedures to swiftly ensure their recalled products are removed from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.

The guidance builds upon systematic improvements to 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 recalls; provided mandatory recall guidance; and issued the final FDA guidance on public warnings and notifications of recalls. The agency has also adopted new policies for moving forward with rapidly posting new recalls to FDA’s Enforcement Report. This includes alerts, advisories, or consumer warnings related to drugs (e.g. Valsartan, Losartan and Irbesartan), homeopathic products and test strips.

For more information please see FDA´s draft guidance “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C”.