June 4 (Reuters) – Abbott Laboratories announced on Saturday the reopening of its Sturgis formula production plant in Michigan, raising hopes of a solution to the unprecedented shortage of infant formula in the United States.
The company said it would resume production of EleCare milk and other specialty formulas and that the first EleCare products would be available to consumers around June 20.
The health regulator, the FDA, said on May 19 that the plant was on track to reopen within a week or two.
Abbott shut down its factory and issued a recall of formula packs in February after reports of bacterial infections in children who consumed formula made at the factory. Two infants died.
These events have exacerbated an already existing shortage of infant formula in the country, while, according to official data for 2020, less than half of infants under the age of three months are exclusively breastfed in the United States.
The results of an FDA inspection of the Sturgis plant were “shocking”, according to regulator Robert Califf.
Among other things, they revealed cracks in essential equipment, a lack of adequate hand washing and evidence of previous bacterial contamination.
The laboratory considers that there is no evidence to establish a link between the production of its preparations and contamination.
The FDA inspection report revealed the presence of bacteria in the production process environment but not in the product samples.
The FDA has signed an agreement with the laboratory to provide oversight of the plant’s compliance.
Before the recall, Abbott controlled 40% of the market share of formula milk, a proportion which tends to fall in favor of other companies such as the ReckittBenckiser group.
Milk supplies could take weeks to return to normal even after the factory reopens, Robert Califf said.
Foreign infant formula manufacturers, such as Danone SA, have sharply increased their shipments of cans to the United States in recent weeks.
(Report by Juby Babu and Manas Mishra Bengalore, French version Caroline Pailliez)