FDA investigation reveals Cronobacter sakazakii traces in Abbott infant nutrition facility

04 Apr 2022 --- An inspection of the Abbott nutrition facility in Sturgis, Michigan has found five environmental subsamples were positive for Cronobacter sakazakii, according to the US Food and Drug Administration (FDA). The investigation comes after reports of illness and death linked to the company’s infant formula.

On-site investigations by the FDA revealed damning observations, including the absence of a process control system that could ensure infant formula does not become adulterated.

Additionally, the company failed to ensure that all surfaces in contact with infant formula were maintained to protect the product from being contaminated by any source.

“Five environmental subsamples collected from the Sturgis facility were positive for Cronobacter sakazakii. Four were detected by the FDA and one was detected through firm-initiated testing,” the FDA highlights.

Product samples analyzed for Cronobacter were found negative.

The inspectional observations in Form 483 do not constitute final FDA determinations.

Questionable sanitary conditions
According to the FDA’s findings, personnel working directly with infant formula, its raw materials, packaging or equipment or utensil contact surfaces did not wear any protective apparel.

Employees at the facility were observed wearing their captive shoes walking in hallways, the cafeteria and exiting the restroom. Additionally, employees, visitors and contractors were not required to spray their captive shoes with sanitizer before entering the production area between January 31 and February 12, according to FDA investigators. 

The FDA completed its facility inspection on March 18 and published its findings in a Form 483, issued when investigators observe conditions they believe violate relevant acts.  

The positive Cronobacter sakazakii environmental samples at the Sturgis facility have been analyzed using Whole Genome Sequencing, revealing five different strains of Cronobacter sakazakii. Four were detected by the FDA, and one was detected through firm-initiated testing.

Sites which tested positive include a high care area, the “scoop hooper,” which is utilized to feed scoops of product going into infant formula containers. Cronobacter sakazakii strains were also found in a support piece of a dryer and the immediate surrounding floor – an area described by the company as medium care.

Similarly, the floor and door swabbed from a zone three surface – also medium care – found strains of the bacteria.

Abbott responds
In February, Abbott voluntarily recalled potentially affected products including Similac, Alimentum and EleCare powdered formulas manufactured at its Sturgis facility after the FDA announced it was investigating four consumer complaints of Cronobacter sakazakii and Salmonella Newport infections.

Agencies in the US, Canada, Australia and China sent out warnings to the public over Abbott infant formula products, as a result.

“All four cases related to these complaints were hospitalized, and Cronobacter may have contributed to a death in one case,” the FDA said at the time. Following the FDA’s publication of Form 483, Abbott issued a statement outlining: “We’re taking this very seriously and are working closely with the FDA to implement corrective actions.”

“While there are actions we need to take to address the FDA observations, it is important to note that no Cronobacter sakazakii or Salmonella was found in any of our testing of products distributed to consumers.”

“Additionally, the unique genetic makeup of the Cronobacter sakazakii microbes found in non-product contact areas at the Sturgis facility did not match the Cronobacter sakazakii microbes from the reported cases. This follows the FDA’s removal of the Salmonella case from its investigation earlier this month.”

Abbott is increasing production of Similac formulas at other FDA-registered facilities.

Evaluating findings
The FDA notes it will take appropriate action in the future – if warranted – as it continues to evaluate the 2022 inspectional findings.

“The FDA is working with Abbott Nutrition to better assess the impacts of the recall and understand production capacity at other Abbott facilities that produce some of the impacted brands. We are also working with Abbott Nutrition on safe resumption of production at the Sturgis, Michigan, facility.”

Abbott adds it has already begun implementing “corrective actions and enhancements” at the facility, including consulting with industry experts to implement the latest technological advancements in food manufacturing processes, including a 3D augmented reality system. 

This will provide a clearer visualization of product as it moves through the facility, enhancing Abbott’s ability to make informed decisions – including remotely – during the manufacturing process.

It will also be enhancing the environmental monitoring program by increasing the sampling of non-product contact areas by two to three times.

By Andria Kades