FDA Releases Draft Guidance for Voluntary Recall Process

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Silver Spring, MD–The U.S. Food and Drug Administration (FDA) announced the agency’s new draft guidance plan that includes steps to strengthen their voluntary recall process through 3 key areas of training, record keeping and procedures, according to a press release.

While the FDA plays an important role in recall processes, the release states that these new steps will help ensure that recalls are initiated properly and promptly.

The draft guidance, “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” provides recommendations for companies that manufacture and distribute FDA-regulated products in order to ready their staff for potential recalls, according to the release. It makes recommendations in the following areas:

  • Training personnel for the responsibilities of a recall: Identifying FDA reporting requirements, establishing a recall communication plan, and more.
  • Record keeping: Thorough record-keeping and proper product coding are vital to a quick response and an accurate recall.
  • Preparing procedures: Written recall initiation procedures that are pre-prepared and maintained can help a recall go smoothly and spread along the full length of a distribution chain.

Dr. Ned Sharpless, FDA acting commissioner, tweeted that “Today’s draft guidance provides industry w/ clear recommendations on ways to prepare, plan, and work with FDA to ensure voluntary recalls are initiated properly and promptly. It reflects the latest step in the agency’s ongoing commitment to working with companies to quickly act to protect consumers from potentially dangerous products and builds upon 18 months of proactive and systematic improvements to the FDA’s recall processes.”

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