ABBOTT PARK, ILL. — Abbott Nutrition hopes to reopen its infant formula plant in Sturgis, Mich., within a few weeks, a move that would go a long way in alleviating the shortage of infant formula.
Abbott Nutrition voluntarily recalled certain products from the facility and suspended operations there after the US Food and Drug Administration on Feb. 17 warned consumers not to use Similac, Alimentum or EleCare from the facility. Four infants, including two who died, became ill after consuming powdered infant formula produced at the Sturgis facility.
Abbott Nutrition announced on May 16 it had agreed to enter into a consent decree with the FDA related to the steps necessary to resume production and maintain the Sturgis facility. The decree was filed in the US District Court for the Western District of Michigan, which must approve the decree.
Once the FDA confirms the initial requirements for starting up the plant have been met, Abbott could restart the site within two weeks, producing EleCare, Alimentum and metabolic formulas first and then Similac and other formulas. Once the plant restarts, products could be available on retail shelves within six to eight weeks.
“Our No. 1 priority is getting infants and families the high-quality formulas they need, and this is a major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage,” said Robert B. Ford, chairman and chief executive officer of Abbott. “We look forward to working with the FDA to quickly and safely re-open the facility. We know millions of parents and caregivers depend on us, and we’re deeply sorry that our voluntary recall worsened the nationwide formula shortage. We will work hard to re-earn the trust that moms, dads and caregivers have placed in our formulas for more than 50 years.”
Some of the corrective actives include reviewing and updating education, training and safety procedures for both employees and visitors as well as updating protocols regarding water, cleaning and maintenance procedures. Abbott Nutrition will be required to retain an independent expert to review the Sturgis facility’s operation to ensure compliance with the law, according to the FDA.
Cronobacter sakazakii was found in the Sturgis plant but in areas not in contact with products, according to Abbott Nutrition. Cronobacter bacteria may cause a blood infection (sepsis) or make the linings surrounding the brain and spinal cord swell (meningitis), according to the Atlanta-based Centers for Disease Control and Prevention.
The CDC performed whole genome sequencing on Cronobacter bacteria isolated from two samples of affected infants. The CDC did not find the two samples to be closely related genetically to the multiple strains of Cronobacter found in the Sturgis facility.The FDA gave data from IRI, a Chicago-based market research firm, to show how infant formula supply is increasing in the United States. National infant formula sales in April were up more than 13% compared to the month prior to the recall, according to IRI, and national infant formula sales by unit in April were up more than 5% compared to the month prior to the recall. Data sets available from IRI show nearly 80% in-stock rates for the week ended May 8.