June 4 (Reuters) – Abbott ABT.N Laboratory announced on Saturday the reopening of its formula production plant in Sturgis, Michigan, raising hopes of a solution to the unprecedented shortage of infant formula in the United States .
The company said it will resume production of EleCare milk and other specialty formulas and the first EleCare products will 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 closed its factory and issued a recall of formula milk boxes 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 three months are exclusively breastfed in the United States.
The results of an inspection of the Sturgis plant by the FDA were “shocking”, according to the head of the regulatory authority, Robert Califf.
They found, among other things, 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 factory’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 RKT.L group.
Milk supplies could take weeks to return to normal even after the factory reopens, Robert Califf said.
Foreign infant milk manufacturers, such as Danone SA
DANO.PA, have greatly increased their deliveries of boxes to the United States in recent weeks. nL5N2XH1OV
(Report by Juby Babu and Manas Mishra in Bangalore, French version Caroline Pailliez)