June 17, 2024

FDA: Abbott Didn’t Test Similac Samples in Internal Probe of Infant Death


Contrary to its own operating procedures, Abbott Nutrition completed an internal probe of a fatal Cronobacter case without testing samples of the associated lot of Similac Pro Total Comfort, according to the FDA’s 2022 inspection report of Abbott’s facility in Sturgis, MI.

Federal health officials have been investigating four Cronobacter illnesses, two of them fatal, reported between September 2021 and January 2022 among infants who consumed Similac products made at Abbott’s Sturgis plant. Yesterday, the U.S. Food and Drug Administration (FDA) released the reports from its three most recent inspections of the Sturgis facility. The reports show that Abbott failed to maintain sanitary conditions at the plant where it makes a variety of infant formulas including some for babies born with special medical needs.

In response to the FDA’s release of the documents, Abbott issued a statement yesterday acknowledging that it needed to address the FDA’s observations and that it had already begun making changes at the Sturgis facility. These actions include increased sampling of finished product and non-product contact areas, implementing auto sampling technology throughout the manufacturing line, and enhancing electronic recordkeeping to “provide immediate real-time information for each batch,” the company said.

Increased testing is a welcome step given that extremely low levels of Salmonella and Cronobacter can cause illness. And that research shows the testing methods manufacturers use aren’t ideally suited to detect such levels. Not mentioned in the response was how Abbott planned to address its failure to maintain the building in a sanitary manner such as how it would eliminate the repeat violation of standing water in the plant, a known source of pathogen growth.

Investigation of Infant Illnesses, Death

In one section of the report from the FDA’s most recent inspection, January 31 to March 18, 2022, the agency addresses missteps in Abbott’s internal probes of illnesses and a fatality. (A second death was reported after the one mentioned in the report.)  The FDA states that in its investigations Abbott failed to identify the root cause of the illnesses, whether there was a health hazard in the plant, how that was determined, and that Abbott treated illnesses and deaths equally in its investigations

The FDA further stated that, contrary to Abbott’s own standard operating procedures for complaint management and investigation, the company did not test retained samples of the product associated with an infant death before closing its internal probe.

FDA inspection detail, lack of product testing in investigation of death

In its February 17, 2022 recall announcement, Abbott stated:  “All finished products are tested for Cronobacter sakazakii, Salmonella Newport and other pathogens and they must test negative before any product is released. Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. And the retained sample related to the complaint for Salmonella Newport tested negative for Salmonella Newport.”

The FDA issued its inspection report on March 18, 2022. Either Abbott wasn’t aware of the testing lapse at the time of the recall, or the FDA alerted the company to the testing failure prior to February 17 and the company then tested the retained product associated with the first death.

Abbott’s statement yesterday did not mention tests of retained products associated with illnesses and deaths. But it did say that the genetic fingerprints of the Cronobacter isolated from the four infants did not match the fingerprint of the Cronobacter swabbed from non-product contact areas at the Sturgis facility.  The Centers for Disease Control and Prevention (CDC), which is conducting whole genome sequencing on the Cronobacter isolates from the four infant patients, has not publically released those results.


Recalled Similac Pro Total Comfort Associated with Cronobacter Death

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