Abbott enters consent decree with FDA

Abbott Nutrition and the US Food and Drug Administration (FDA) have entered into a consent decree that will enable powdered infant formula production to restart at the company’s Sturgis, Michigan facility in as little as two weeks.

Once production has recommenced, the company estimates it will take from six to eight weeks for product to reach store shelves.

Operations at the Sturgis facility were halted in February 2022, after four infants became ill with Cronobacter sakazakii infections. The infants were fed four different Abbott products: Similac Sensitive, Similac Pro-total Comfort, Similac Advance, and Similac PM 60/40.

Two of the infants died.

According to a statement released by the FDA, under the proposed consent decree, Abbott Nutrition will be required to retain an independent expert to review the Sturgis facility’s operations to ensure compliance with the law.

The proposed decreee also includes requirements for testing products, as well as ceasing production, and promptly notifying the FDA should contamination be detected, as well as the implementation of a sanitation plan, environmental monitoring plan and employee training programs.

The proposed consent decree was filed in U.S. District Court for the Western District of Michigan, and is subject to court approval.

“No conclusive evidence”

In its news release, Abbott emphasized that the FDA and CDC investigations found “… no conclusive evidence to link Abbott’s formulas to these infant illnesses.”

The company listed the following findings of the investigations

CDC concluded its investigation with no findings of a link between Abbott formulas and infant illnesses.
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.
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.
Genetic sequencing on the two available samples from ill infants did not match the strains of Cronobactersakazakii found in our plant. Samples from ill infants did not match each other, which means there was no connection between the two cases.
In all four cases, the state, FDA and/or CDC tested samples of the Abbott formula that was used by the child. In all four cases, all unopened containers tested negative.
Open containers from the homes of the infants were also tested in three of the four cases; two of the three tested negative. The one positive was from an open container from the home of the infant, and it 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. Again, neither strain matched strains found in our plant.
The infants consumed four different types of our formula made over the course of nearly a year and the illnesses took place over several months in three different states.

What FDA found

During the intensive investiation carried out by twelve-person team, the FDA documented multiple failings at Abbott’s Sturgis facility.

These included,

Cronobacter sakazakii found in multiple locations in “medium and high care areas of powdered infant formula production, including the hinge attachment and bolt heads on the cover of a scoop hopper for a filler line in the packaging room.
FDA found evidence of Cronobacter sakazakii in a dryer.
Review of company’s records indicated two finished product batches had tested positive for Cronobacter sakazakii.
Water dripping onto the floor in the production area from valves.
Standing water in powdered infant formula production areas (a repeat observation that was first made during the FDA’s September 2021 inspection of the facility and which had not yet been corrected).
Review of company’s records showed a history of internal deterioration in spray dryers dating back to September 2018.
Abbott’s complaint investigations on four consumer complaints (three dealing with Cronobacter sakazakii illnesses and one with a Salmonella Newport illness) did not identify the root causes of the illnesses
During an investigation into the death due to Cronobacter sakazakii of an infant who had been fed Similac Pro Total Comfort infant powder formula, the company’s investigation team did not request that retain samples from the implicated batch of product be tested, even though the company’s own Standard Operating Procedure required this to be done.

During a routine inspection of the Sturgis plant carried out in September 2021, the FDA reviewed complaints received by the company in the two years since its previous inspection. These included:

One complaint of a Cronobacter sakazakii illness in an infant fed Similac Pro-Sensitive powdered formula
One death of an infant fed three different production lots of Similac Alimentum
Fifteen complaints of Salmonella infections in infants fed various Similac or Elecare products. Although an unopened finished product sample was obtained from one of the fifteen cases, no microbiological analysis was conducted on the sample.

All of the complaints were closed by the company following internal investigations.

What next for Abbott?

While there is no smoking gun to conclusively link Abbott’s powdered infant formula products with the four Cronobacter sakazakii illnesses and two deaths, circumstantial evidence is strong, despite the company’s protest to the contrary.

All four victims were fed a product manufactured in Abbott’s Sturgis, Michigan facility
The Sturgis facility had numerous, longstanding maintenance issues, some of which (such as cracks in dryer surfaces) would have increased the risk of chronic pockets of contamination in and on production equipment.
Both the company and the FDA recovered Cronobacter sakazakii from environmental swabs during the 2022 investigation.
Abbott had a history of bacterial illness complaints (15 Salmonella, one Cronobacter sakazakii and one unspecified) during the two years immediately prior to the first reported outbreak case.

At least three separate lawsuits have been filed against the company by parents who believe their babies were made ill as a result of having been fed one of the Abbott powdered infant formula products.

As Rachel Maddow of MSNBC would say, “Watch this space.”

Learn more about Cronobacter sakazakii and other foodborne disease outbreaks in TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures, now available in digital, print and audiobook editions.