FDA 'inadvertently archived' complaint about Abbott infant formula plant, audit says

The Food and Drug Administration (FDA) has acknowledged that it 'inadvertently archived' a consumer complaint about the Abbott infant formula plant in Michigan, which led to a nationwide recall and a shortage of formula in 2022. An audit by the Department of Health and Human Services' Office of Inspector General (OIG) found that the FDA did not properly investigate the complaint. The complaint, received in September 2021, alleged that a baby had been hospitalized after consuming formula manufactured at the plant. The FDA initially deemed the complaint as "low priority" and closed it without any follow-up investigation. The audit also found that the FDA's inspection of the plant in January 2022 was "inadequate." The agency failed to identify the root cause of the contamination and did not take steps to prevent similar incidents from happening in the future. The OIG report concluded that the FDA's failures "contributed to the delayed identification of the safety concerns with the formula products." The recall of the formula, which was linked to four infant deaths, began in February 2022. The FDA has accepted the OIG's recommendations and is taking steps to improve its oversight of infant formula manufacturers. The agency has also committed to working with Congress to improve the safety of infant formula. The Abbott infant formula plant in Michigan remains closed. The recall and subsequent shortage of infant formula highlighted significant vulnerabilities in the US food supply chain, leading to increased scrutiny of the FDA's regulatory oversight.

Summary

"The FDA's mishandling of a consumer complaint about the Abbott infant formula plant has been criticized by an audit, which found that the agency failed to properly investigate the complaint and did not take steps to prevent similar incidents from happening in the future. The audit's findings have raised concerns about the FDA's regulatory oversight of the infant formula industry."