The US Food and Drug Administration (FDA) has identified five different strains of Cronobacter sakazakii in environmental samples collected during an inspection of Abbott Nutrition’s Sturgis, Michigan production plant.
In a March 31, 2022, update to its outbreak investigation report, the FDA stated that four of the strains were recovered from samples taken by the agency’s team of inspectors. The fifth strain was from a sample collected by the firm.
The US Centers for Disease Control and Prevention (CDC) has completed a whole genome sequencing (WGS) of the Cronobacter sakazakii cultures obtained from two of the four infected infants.
Neither of the clinical cultures matched any of the five strains found in Abbott’s production environment.
Outbreak and recall
The FDA’s investigation of Abbott’s manufacturing facility was triggered by four reports of infants who had become infected with Cronobacter sakazakii after having been fed a powdered infant formula manufactured by Abbott Nutrition.
The first report was received by the FDA on September 6, 2021. The most recent illness began on January 4, 2022.
Two of the four infected infants have died.
According to the FDA, Cronobacter sakazakii infection “may have contributed” to their deaths.
Abbott Nutriton initiated a product recall on February 12, 2022. The recall was expanded on February 28, 2022.
Cronobacter sakazakii is a cause of necrotizing enterocolitis and meningitis in newborns, and is often fatal. In older babies, children and adults, this opportunistic pathogen can cause respiratory infections and sepsis.
Symptoms in newborns include fever, rapid heart rate, seizures and other neurological abnormalities.
The FDA’s in-depth inspection of the Abbott’s manufacturing plant began on January 31, 2022 and was completed on March 18th.
The Inspectional Observations report (FDA Form 483) issued at the end of the inspection listed eight pages of infractions and deficiencies.
One of the most serious observations related to the maintenance of the company’s spray-drying equipment.
On reviewing the company’s own documentation, the FDA inspection team noted “a history of internal deterioration [of the dryers] dating back to September 2018.“
According to the records of the most recent dryer inspections, carried out in August 2021, two different dryers showed six instances each of cracks, pits, and/or damage in the main chamber.
A further example of improper maintenance was documented by three separate work orders during the course of a year for repair of a “water event” at the same inlet to a spray-dryer. The work orders were issued on February 1, 2021, November 4, 2021, and January 21, 2022.
A parallel can be drawn between the dryer maintenance issues at Abbott and a similar situation in Australia in the 1970s.
In 1977, powdered infant formula manufactured by three different companies was determined to be the source of a number of Salmonella Bredeney infections in the state of Victoria, Australia.
All three companies obtained their powdered milk from the same manufacturer.
When inspectors visited the powdered milk supplier’s manufacturing plant, they discovered that the interior of the cone-shaped base of the spray dryer had developed several cracks.
The company tried to repair the cracks by welding them shut. When the welds failed, the company continued to use the spray dryer, but simply discarded the powder that collected in the base of the drying chamber.
Environmental samples from the interior of the spray-dryer determined that its fiberglass insulation material had become saturated with Salmonella.
In an update posted on the company’s website, Abbott responded to the FDA’s report by reassuring consumers of its cooperation with the FDA, while at the same time emphasizing that the strains of Cronobacter sakazakii found in the production environment did not match those recovered from the infected infants.
Abbott has “already begun implementing corrective actions and enhancements at the facility, leveraging new technology and strengthening our processes, to give parents and customers renewed confidence in the quality of manufacturing at our Sturgis plant when we restart operations there,” according to the company’s statement.
Who to contact for more information
If you want to check if your powdered formula is part of the recall, you can enter the product lot code on the bottom of your package on the company’s website.
If you have questions for the FDA or need information about the recall, you can Submit Questions/Get Assistance.
If your infant is experiencing symptoms related to Cronobacter infection, such as poor feeding, irritability, temperature changes, jaundice, grunting breaths, or abnormal body movements, contact your health care provider to report their symptoms and receive immediate care.
To report an illness or adverse event, you can
- Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
- Complete an electronic Voluntary MedWatch form online.
- Complete a paper Voluntary MedWatch form that can be mailed to the FDA.
Learn more about the history of Cronobacter sakazakii and other foodborne disease microbes in TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures.
TAINTED is available in digital and audiobook editions from all major on-line retailers or in print edition from Amazon.
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Genomic analysis of Cronobacter isolates from Michigan can be viewed here on YouTube: https://youtu.be/A_VmlLN0b30
Also, genomic analysis of clinical and breast pump Cronobacter isolates can be found here: https://youtu.be/rJO9O3zadBk