COLUMBUS, Ohio — Abbott responded to reports that it failed to maintain sanitary conditions at one of its manufacturing plants on Wednesday, detailing new actions to prevent future infant illnesses linked to its baby formula.
Initial inspection findings from the Food and Drug Administration allege an Abbott plant in Sturgis, Michigan, did not maintain clean surfaces when handling powdered formula linked to several infant hospitalizations, including two deaths. In response, Abbott recalled various lots of three popular powdered infant formulas last month.
Inspectors claim the illnesses and deaths were linked to a bacteria, known as cronobacter, and said the Michigan plant has a contamination history involving that bacteria – including eight incidents reported between fall 2019 and February of this year.
Abbott argued that the bacteria microbes found inside the Sturgis facility were in areas where there is no product and did not match the genetic makeup of microbes from the reported cases.
“We're taking this very seriously and are working closely with the FDA to implement corrective actions,” an Abbott spokesperson said in a statement to 10TV on Wednesday.
According to Abbott, those actions include attempting to update its food manufacturing processes with the latest technology, increasing finished product testing, implementing technology that would detect potential issues earlier on, and enhancing facility environmental monitoring programs, as well as electronic records.
As for a baby formula shortage, Abbott said it has increased production at an FDA-registered facility in Europe and is flying in Similac Advance product daily to the United States.
10TV found at least one class action lawsuit has been filed in the United States District Court Southern District of Florida Miami Division against Abbott connected to the recall.
“We know that millions of parents and caregivers around the world count on our formulas to feed their babies and children and we are doing everything possible to address this situation,” the statement from Abbott reads.