Months after it stopped production and recalled its products, worsening a pandemic formula shortage, Abbott has entered into a consent decree with the U.S. Food and Drug Administration, making way for the pharmaceutical company to re-open its infant formula plant in Sturgis, Abbott announced Monday.
Once the FDA confirms the initial requirements have been met, it could restart the site in southwest Michigan within two weeks, Abbott reported in a statement. It would begin producing EleCare, Alimentum and metabolic formulas first and then start making Similac and other formulas. From the time work resumes at the site, it will take six to eight weeks before product is available on shelves.
“Our number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage. We look forward to working with the FDA to quickly and safely re-open the facility,” Robert B. Ford, chairman and chief executive officer, said in the statement.
“We know millions of parents and caregivers depend on us and we’re deeply sorry that our voluntary recall worsened the nationwide formula shortage. We will work hard to re-earn the trust that moms, dads and caregivers have placed in our formulas for more than 50 years.”
The proposed consent decree obliges Abbott to take actions expected to ultimately result in an increase of infant formula products, while ensuring that the company manufactures safe powdered formula at the facility, the FDA reported.
Parents for months have struggled to find formula in grocery stores, where large swathes of shelves are often empty. Mothers and fathers have reported visiting various stores in search of what they need, and the Michigan Department of Health and Human Services and other agencies have urged parents not to resort to potentially harmful alternatives, such as watered-down formula, homemade formula or cow’s milk for infants.
RELATED: ‘Every store I went to had nothing.’ Baby formula recall hits Michigan parents hard
In February, Abbott Nutrition recalled certain powdered infant formula products produced in its Sturgis facility because of consumer complaints related to Cronobacter sakazakii or Salmonella Newport infection. Cronobacter bacteria can cause severe, life-threatening sickness. Salmonella are a group of bacteria that can bring about gastrointestinal illness and fever.
Five illnesses tied to the possible contamination were reported. Two resulted in death, according to the FDA. There were no known Michigan illnesses with confirmed links to the recalls, a state health department spokesperson earlier said.
In a complaint, filed by the U.S. Department of Justice on behalf of the FDA, the government alleges that powdered infant formula products manufactured at Abbott Nutrition’s Sturgis facility were adulterated because they were made under “insanitary conditions and in violation of current good manufacturing practice requirements,” the FDA reported.
According to Abbott, there is no conclusive evidence to link its formulas to these infant illnesses, the FDA, Centers for Disease Control and Prevention and Abbott found in an investigation and review of all available data.
The recall especially hit hard low-income Michigan families. About 85% of formula-fed participants in the federally funded Women, Infant and Children program were potentially affected, the state health department earlier reported.
Through a competitive bidding process required by the U.S. Department of Agriculture, the state entered in November into an exclusive five-year contract with Abbott Laboratories, based in Illinois. Since the recall, however, WIC participants have been permitted to purchase alternate formula brands.
Abbott has been working on corrective actions since a January FDA “for cause” inspection, which the FDA says revealed “significant operational deficiencies,” and submitted a response and corrective action plan to on April 8. Abbott reports it has been reviewing and updating education, training and safety procedures for both employees and visitors; and updating protocols regarding water, cleaning and maintenance procedures at the facility.
Under the proposed consent decree, Abbott will be required to retain an independent expert to review the Sturgis facility’s operations. It also includes mandates for testing products, ceasing production, and promptly notifying the FDA should contamination be detected, the FDA says.
“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,” FDA Commissioner Dr. Robert M. Califf said in a statement. “We recognize the hardships that parents and caregivers have faced in obtaining infant formula and the FDA is focused on boosting the availability of the country’s supply of these products.”
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