Abbott releases plans to reopen Sturgis plant, provides infant formula recall update
STURGIS, Mich. — Abbott's Sturgis plant could reopen within the next two weeks, subject to FDA approval, Abbott representatives announced Wednesday on their online newsroom.
However, consumers wouldn't see products on shelves for about six to eights weeks after the plant reopens.
The company recognized the recall worsened the infant formula shortage.
"We deeply regret the situation and since the recall, we've been working to increase supply at our other FDA-registered facilities, including bringing in Similac from our site in Cootehill, Ireland, by air and producing more liquid Similac and Alimentum," Abbott representatives said.
Metabolic formulas have also started being released that were on hold, according to Abbott representatives.
The Sturgis plant closed after voluntarily recalling some products involved in complaints.
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There were four complaints of an environmental bacteria found in infants who consumed formulas produced at the Sturgis plant. Two infants became sick and two died, according to Abbott representatives.
However, investigations showed no evidence linking Abbott formulas to the infant illnesses.
"All finished product testing by Abbott and the FDA during the inspection of the facility came back negative for Cronobacter and/or Salmonella. No Salmonella was found at the Sturgis facility," company representatives announced.
The environmental bacteria found during the investigation was in non-product contact areas of the facility and was not linked to any known infant illness.
Genetic sequencing on two available samples from ill infants did not match the strains of the environmental bacteria found in the plant. The two samples also did not match each other, meaning the two cases were not connected.
More information on the additional tests in the recall investigation can be found online.
The FDA concluded the investigation on March 18 with a list of improvements to Abbott's systems and protocols.
Corrections have been implemented and upgrades to the Sturgis plant have been made, according to company representatives.
"Some of these actions have included reviewing and updating education, training and safety procedures for both employees and visitors, as well as updating our protocols regarding water and cleaning and maintenance procedures at the facility," company representatives said.
"We understand the situation is urgent – getting Sturgis up and running will help alleviate this shortage," Abbott representatives said.
