Abbott Laboratories has struck an agreement with the US Food and Drug Administration to take “corrective action” at its Sturgis infant-formula plant.
The site in Michigan, which halted production of formula in February following a voluntary recall amid fears of the presence of Cronobacter sakazakii or Salmonella, could reopen in two weeks “once the FDA confirms the initial requirements for start-up have been met”, Abbott said in a statement yesterday (16 May).
However, Abbott reiterated it may take six to eight weeks for products from the Sturgis factory to arrive on retailers’ shelves, prolonging a shortage of infant formula in the US.
In the meantime, the FDA has been in discussions with other manufacturers such as Nestlé-owned Gerber and Reckitt Benckiser, which, the agency said, “are all producing at an expanded capacity”. Yesterday, the FDA announced it had “increased flexibilities regarding importation of certain infant-formula products to further increase the availability of infant-formula across the country while protecting the health of infants”.
The so-called “consent decree” between Abbott and the FDA has been filed with the US District Court for the Western District of Michigan.
“The proposed consent decree obliges Abbott to take actions that are expected to ultimately result in an increase of infant-formula products, while ensuring that the company undertakes certain actions that would ensure safe powdered infant formula is produced at the facility,” the FDA said in a separate statement yesterday.
It added: “When the company decides to restart production at this facility, it must conform with the provisions of the proposed consent decree and meet FDA food-safety standards. If contamination is identified, the company must notify the FDA, identify the source of the problem and conduct a root-cause investigation before resuming production.”
On 17 February, the FDA warned consumers not to “use certain powdered infant-formula products” produced at Abbott’s facility. The company then recalled its Similac, Alimentum and EleCare brands after four consumer complaints related to Cronobacter sakazakii or Salmonella in infants who had consumed powder infant-formula manufactured at the Sturgis plant. Two of the children died.
Abbott said “there is no conclusive evidence to link Abbott’s formulas to these infant illnesses” following an investigation in conjunction with the FDA and the Centers for Disease Control and Prevention (CDC).
The company explained further: “Abbott conducts microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for Cronobacter sakazakii or Salmonella. All retained product tested by Abbott and the FDA during the inspection of the facility came back negative for Cronobacter sakazakii and/or Salmonella. No Salmonella was found at the Sturgis facility.”
Abbott added: “The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of the facility and has not been linked to any known infant illness.”
In tests carried out on open infant-formula containers in three of the four homes of the infants concerned, two tested negative, while one “tested positive for two different strains of Cronobacter sakazakii, one of which matched the strain that caused the infant’s infection, and the other matched a strain found on a bottle of distilled water in the home used to mix the formula”, Abbott said, adding “neither strain matched strains found in our plant”.
Nevertheless, US publication Politico has reported that the FDA had knowledge of the first case of illness in September. Politico says the agency was also warned about food-safety concerns at the Sturgis plant by a whistleblower in October.
Once production restarts upon FDA clearance, Abbott said it will initially prioritise manufacture of its EleCare and Alimentum metabolic formulas followed by its Similac and other powders.
Chairman and CEO Robert Ford said: “Our number one 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. We will work hard to re-earn the trust that moms, dads and caregivers have placed in our formulas for more than 50 years.”
Abbott noted it has been working on “corrective actions” at the Sturgis plant since the FDA inspection, submitting a forward plan on 8 April. The company has started improving and upgrading the site, including training and safety programmes, as well as “updating protocols regarding water, cleaning and maintenance procedures”.
To compensate for the supply shortfall, Abbott has focused production at its Cootehill plant in Ireland to serve US state Special Supplemental Nutrition Program for Women, Infants and Children (WIC). It has also “prioritised” infant-formula production at its Columbus, Ohio, facility, and ramped up output at its site in Casa Grande, Arizona.
Robert Califf, the FDA commissioner, emphasised a commitment to get products on shelves on the back of the regulator’s steps taken to boost imports. “The public should rest assured that the agency will do everything possible to continue ensuring that infant and other specialty formulas produced by the company meet the FDA’s safety and quality standards,” he said.
“We recognise the hardships that parents and caregivers have faced in obtaining infant formula and the FDA is focused on boosting the availability of the country’s supply of these products, including new steps regarding importation.”
The FDA cited data from IRI showing the increased ramp-up by Gerber and Reckitt is having an effect on availability. “Sales by volume for the month of April were up more than 13% compared to the month prior to the recall, and national infant-formula sales by unit for the month of April are also up by more than 5% compared to the month prior to the recall,” it said.