Major Formula Maker Resumes Production at US Facility

The Abbott Laboratories facility where dozens of recalled types of powdered baby formulas were made leading to production being halted at the location, in Sturgis, Mich., on May 20, 2022. Eric Cox/Reuters

The baby formula manufacturer whose facility was shut down earlier this year has resumed production at the factory.

Abbott announced over the weekend that it restarted formula production at the Sturgis, Michigan, facility.

The resumption comes after Abbott met initial requirements outlined in a consent decree it recently reached with the U.S. Food and Drug Administration (FDA).

Abbott is focusing on producing specialty formulas like EleCare, which is designed for infants who cannot consume intact or hydrolyzed protein.

The first products being produced are expected to be available to consumers on or around June 20.

“We’re also working hard to fulfill the steps necessary to restart production of Similac and other formulas and will do so as soon as we can,” Abbott said in a statement.

“We understand the urgent need for formula and our top priority is getting high-quality, safe formula into the hands of families across America. We will ramp production as quickly as we can while meeting all requirements. We’re committed to safety and quality and will do everything we can to re-earn the trust parents, caregivers and health care providers have placed in us for 130 years,” it added.

The shutdown of Abbott’s plant in February, after an FDA inspection uncovered unsanitary conditions, led to a nationwide shortage of formula that is expected to last for at least several additional weeks despite the agency relaxing import restrictions and taking other steps to try to address the problem.

The FDA first became aware of possible issues at the plant months earlier. The agency’s actions are being investigated by the Department of Health and Human Services’ inspector general.

Illnesses from Cronobacter sakazakii, a type of bacteria, cropped up in four American infants in 2021. Environmental samples from the Sturgis plant tested positive for the bacteria, but testing of the products themselves found the strains of Cronobacter were different from those that caused the illnesses. Still, officials found signs Abbott had destroyed some products, and Abbott voluntarily recalled products produced at the plant.

A federal judge on May 16 signed the agreement between the FDA and Abbott, which stipulated that Abbott must hire an outside expert to evaluate the facility for compliance with agency rules, including proper time and temperature controls for production equipment.

Abbott was told to collect samples during production and have them analyzed for both Cronobacter and Salmonella. If either is found, Abbott agreed to dispose of contaminated batches and stop production until the FDA notifies the company it can resume production.