FDA to investigate delay responding to infant formula plant safety concerns
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FDA to investigate delay responding to infant formula plant safety concerns

US Food and Drug Administration (FDA) Commissioner Robert Califf Monday announced the agency will investigate the delay in dispatching investigators to the Abbott Nutrition infant formula plant in Michigan. This as Abbott Monday announced a plan to restart the Michigan plant in two weeks, in accordance with an FDA consent decree.

The FDA and the Centers for Disease Control (CDC) initially launched an investigation into Abbott in late January 2022. The agency subsequently filed an advisory alert to consumers in February. Abbott also voluntarily recalled certain infant formulas linked with the Michigan plant, and the plant was shut down. The FDA launched the investigation after receiving consumer complaints of infant illnesses related to baby formula products from Abbott’s Michigan plant. The first complaint was filed in September 2021. All four reported complaints included infant hospitalization, including two deaths.

Additionally, a former Abbott employee filed a whistleblower complaint concerning food safety violations at the Michigan plant with the FDA in October 2021. The complaint detailed numerous safety concerns, including a culture of a lax approach to safety procedures. The former employee alleges Abbott officials manipulated testing procedures and purposefully concealed quality concerns, including the discovery of bacteria in a 2019 batch of the plant’s infant formula, from FDA officials.

In an interview on NBC’s “Today” show, Califf confirmed that the FDA would conduct a full investigation into the timeline surrounding the Abbott recall. When asked if the FDA was slow to respond, Califf said “[W]e’ll do everything possible to correct any errors in timing that we had so that we don’t repeat any mistakes that may have been made.”

The issues at Abbott’s Michigan plant come in the midst of a nationwide infant formula shortage in the US. The shortage is believed to be a result of supply chain disruptions, labor shortages and the Abbott plant issues.

In light of that and the conclusion of the FDA investigation, the Department of Justice Monday filed a consent decree with Abbott in the Western District of Michigan on behalf of the FDA. The proposed decree would have Abbott agree to take corrective actions at the Michigan plant ensuring the safety and increased production of infant formula at the site. Should any contamination be identified at the plant, Abbott must notify the FDA, locate the source of the problem and conduct an investigation before resuming production. The consent decree also confirms that the reported infant formulas from Abbott’s Michigan plant were adulterated because they were produced under unsanitary conditions in violation of good manufacturing policies.

Abbott Monday agreed to the consent decree. As a result the Michigan plant could resume production in as little as two weeks. The decree is still subject to court approval.