FDA Seeks to Have Manufacturers Prepared to Act Quickly on Recalls

The guidance urges manufacturers to maintain good record keeping and product coding which helps facilitate faster recall responses.

Federal food and drug regulators are calling on manufacturers throughout the United States to be “Recall Ready,” and improve their recall response strategies to better protect the health and safety of the general public.

Medications, food, cosmetics, and medical devices are often not recalled until after they have already caused serious side effects, ranging from minor to major illness, hospitalization and even death. On March 3, the Food and Drug Administration (FDA) announced the publication of a final guidance on the initiation of voluntary recalls, which calls on manufacturers of drugs, devices, biological products, food, cosmetics and tobacco to establish plans that will ensure quicker responses when problems are found with their products.

The guidance is intended to help companies prepare to quickly and effectively remove recalled products from the market, and minimize further risk to consumers. It includes steps the companies should take before a recall is necessary, and calls on companies to develop policies and procedures that include training, planning and record-keeping, to reduce the time a recalled product is on the market and limit the public’s exposure to risk from the product.

The entire guidance highlights the need for companies to ensure recall actions are taken quickly to protect public health.

A voluntary recall is an action taken by a company to correct concerns regarding a product or to remove the product from the market if it may be unsafe for the public. The company can act on its own to initiate a voluntary recall after discovering a problem, or the FDA can recommend a voluntary recall after informing a company their product that violates the law or poses a potential safety risk.

Additionally, the FDA can also require recalls of some products, such as controlled substances, biological products, human cells, tissues, medical devices and foods, but that process often takes additional time.

The guidance indicates companies should have product coding established and maintain distribution records to facilitate faster, more accurate recalls. Additionally, manufacturers should use electronic communications to quickly identify and provide product information about recalls. Companies should establish procedures to inform the entire distribution chain, including wholesalers and vendors, of recalls quickly.

“It is critical that all companies in the supply chain are ‘recall ready’ to ensure appropriate actions are taken swiftly across the distribution channels to best protect public health and the integrity of the supply chain,” wrote Associate Commissioner of Regulatory Affairs Judith McMeekin. “We will continue to work with companies to improve their recall procedures and minimize Americans’ exposure to potentially harmful products.”

The emphasis of the entire guidance is for manufacturers to be “Recall Ready” and to initiate recalls quickly, even before completing an investigation into the problem, to ensure the least amount of harm is posed to consumers.

The draft version was introduced in April 2019 and the FDA indicates only minor changes were made to that original version.