Earlier this month, the U.S. Food and Drug Administration (“FDA”) completed guidance to help companies remove violative products from the market in a swift and effective manner. The guidance describes the precautionary steps companies should take to develop recall policies and procedures that include training, planning, and recordkeeping to reduce the amount of time a recalled product is exposed to the public.
The FDA’s final guidance explains a variety of best practices for establishing, implementing and training on a recall plan. Some recommendations include:
- Using an adequate product coding and maintain distribution records to facilitate quicker, and more accurate recall actions.
- Developing recall procedures to swiftly inform their entire distribution chain of the recall, thus, consignees can rapidly identify affected lots and recall downstream products when necessary.
- Using electronic communications to quickly identify and provide certain product detail when alerting consignees and the public about a voluntary recall.
- Acting quickly to initiate a recall when the public’s health is at risk prior to completing an investigation into the cause of the recall.
Over the past several years, FDA has issued a variety of guidance documents to made proactive and systemic improvements to the recall process. These guidance documents include the following topics:
The FDA’s guidance reflects the agency’s ongoing commitment to work closely with companies so they can quickly act to protect the public from violative products on the market.
Written with the assistance of Sabrina Bey, a Fall Clerk in the Husch Blackwell LLP Washington, DC office.
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