Abbott Nutrition announced on Saturday that its Sturgis, Mich., facility is resuming its production of infant formula and estimated that its EleCare infant formula would be back on shelves beginning around June 20.
Abbott said in a statement that initial requirements as part of a consent agreement it reached with the Food and Drug Administration (FDA) last month had been met, allowing the baby formula manufacturer to restart its operations.
“Abbott is starting production of EleCare and other specialty and metabolic formulas, with initial EleCare product release to consumers beginning on or about June 20,” Abbott said. “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.”
“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,” the manufacturer added.
Abbott recalled several of its powdered products including Similac, Alimentum and EleCare in February after four cases of a rare bacterial illness contracted by babies who were allegedly fed the formula.
The facility halted production and federal officials conducted an investigation of the plant.
The shutdown was one of the factors that lead to a nationwide shortage of formula along with supply chain snarls and other factors.
Different strains of Cronobacter were found within the facility, but Abbott says they are not to blame, asserting that the Cronobacter detected in its plant does not match samples from several infants who became ill from the baby formula.
The FDA said officials were on site at the Michigan facility to examine the equipment, roofing and flooring in addition to environment testing conducted by both an independent expert and Abbott.
Other requirements as part of their consent decree that Abbott needed to meet included giving the FDA an independent expert report and verifying certain procedures.
“The agency expects that the measures and steps it [the company] is taking, and the potential for Abbott Nutrition’s Sturgis, Michigan, facility to safely resume production in the near-term, will mean more and more infant formula is either on the way to or already on store shelves moving forward,” an FDA spokesperson said in a statement.
The development comes as FDA Commissioner Robert Califf warned late last month that it would not be until likely late July before the nationwide infant formula shortage ends.
