Abbott Laboratories and the U.S. Food and Drug Administration have come to an agreement on the steps the company must take before it can restart production of infant formula at a Michigan facility — a move that could help alleviate a national infant formula shortage.
Abbott has agreed to enter into a consent decree with the FDA, which was filed in U.S. District Court for the Western District of Michigan on Monday. The decree must still be approved by the court.
In a complaint leading to the decree, the federal government alleges that powdered infant formulas made at Abbott’s Sturgis, Mich., facility were adulterated because they were made under insanitary conditions and in violation of good manufacturing practice requirements. As part of the consent decree, Abbott must hire an independent expert to review the Sturgis facility’s operations. The decree would also put in place requirements for testing products and require expert review and implementation of a sanitation plan, environmental monitoring plan and employee training programs.
North suburban-based Abbott said in a news release Monday that it expects to be able to restart production within two weeks, once the FDA determines Abbott has met the initial requirements of the agreement. Once it resumes production, Abbott could have some of its formulas produced at the plant back on store shelves within six to eight weeks after that.
Abbott Chairman and CEO Robert Ford called it a “major step” toward reopening the Michigan facility, in the Abbott news release.
“We know millions of parents and caregivers depend on us and we’re deeply sorry that our voluntary recall worsened the nationwide formula shortage,” Ford said. “We will work hard to re-earn the trust that moms, dads and caregivers have placed in our formulas for more than 50 years.”
FDA Commissioner Dr. Robert Califf said in a separate FDA news release that: “Today’s action means that Abbott Nutrition has agreed to address certain issues that the agency identified at their infant formula production facility in Michigan. The public should rest assured that the agency will do everything possible to continue ensuring that infant and other specialty formulas produced by the company meet the FDA’s safety and quality standards, which American consumers have come to expect and deserve.”
Abbott recalled a number of the infant formulas produced at its Sturgis plant in February as the FDA announced that it was investigating complaints of Cronobacter sakazakii infections among four babies who reportedly consumed formula made there. All four were hospitalized, and Cronobacter may have contributed to two babies’ death, according to the FDA.
At the time, Abbott recalled its Similac, Similac Alimentum and EleCare powder formulas made at the plant.
The FDA inspected the facility from Jan. 31 through March 18 and found five environmental subsamples collected from the Sturgis facility to be positive for Cronobacter sakazakii, though product samples collected by the FDA at the facility were negative for Cronobacter.
Abbott said the Cronobacter that was found in environmental testing during the investigation was in “non-product contact areas of the facility and has not been linked to any known infant illness.”
The FDA also, however, found issues with certain processes and procedures at the plant, during its inspection.
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Abbott said it has addressed those issues. It has reviewed and updated its education, training and safety procedures for employees and visitors; updated its protocols related to water and cleaning and maintenance procedures; and has been upgrading the plant, including by installing nonporous, “easily cleanable and sanitary floors,” Abbott said in a statement.
Infant formulas have been tough to find for months, with the recall exacerbating a shortage caused partly by supply chain issues. Many grocery stores and retail pharmacy chains, including Jewel-Osco, Walgreens and CVS Health, are limiting how much formula people can buy at one time.
In the Chicago area, about 34% of formulas were out of stock at local stores the first week of May, up from 28% at the beginning of March, according to Datasembly, a company that scrapes data from retailers’ publicly available websites and apps to gauge product availability. During the first half of 2021, only about 2% to 8% of formulas were out of stock nationwide.
The FDA, however, said in its news release Monday that nationwide nearly 80% of formulas were in-stock the first week of May, according to Information Resources Inc.
The FDA said Monday given the possibility of Abbott’s facility restarting production soon along with increased production of formula by other manufacturers, “the FDA expects supply to continue to improve over the next couple of months.”