FDA Urges Companies to be 'Recall Ready’ to Protect Public Health as Part of Final Guidance for Voluntary Recalls

Final guidance to help companies prepare to quickly and effectively remove violative products from the market

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS . FDA Urges Companies to be 'Recall Ready' to Protect Public Health as Part of Final Guidance for Voluntary Recalls Today, the U.S. Food and Drug Administration finalized guidance to help companies prepare to quickly and effectively remove violative products from the market. The guidance describes steps companies should take, before a recall is necessary, to develop recall policies and procedures that include training, planning and record-keeping to reduce the time a recalled product is on the market and, thus, limit the public's exposure to risk.  A voluntary recall is an action taken by a company to correct a violative product or remove it from the market. A recalling company may act on its own initiative or the FDA may inform the company that a distributed product violates the law and recommend the company recall the product. The FDA has the authority to require recalls of certain products in particular circumstances, such as controlled substances, biological products, human cells, tissues and cellular and tissue-based products, medical devices and foods.  The final guidance, Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C, explains how companies should have adequate product coding and maintain distribution records to facilitate faster, more accurate recall actions, which the FDA recommends that all companies do. It encourages recalling companies to use electronic communications to quickly identify and provide certain product information when alerting consignees and the public about a voluntary recall.  The guidance also urges companies to act quickly to initiate a recall when public health is at risk and to do so prior to completing an investigation into the cause of the problem. Because recalls can affect the entire supply chain, including downstream suppliers, wholesalers or vendors, the FDA recommends that companies develop recall procedures to quickly inform their entire distribution chain, so consignees can rapidly identify affected lots and recall downstream products when necessary.  Learn More The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research  provides guidance, education and updates for regulated industry. Subscribe to CDER SBIA Email Updates Register for Upcoming Training View 2021 Recordings on YouTube Follow on LinkedIn Follow on Twitter This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.  SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA