June 23, 2022

Whistleblower Report Alleges Abbott Lax on Contaminated Infant Formula

A new whistleblower report alleges that Abbott Nutrition was lax on concerns about contaminated infant formula, according to information released by Representative Rosa DeLauro (D-CT). DeLauro is the House Appropriations Committee Chair. She submitted the report for the record on April 28, 2022. The whistleblower allegedly worked at the Abbott facility that produces infant formula that was recalled for possible Cronobacter contamination in February 2022. In September 2021 the FDA learned of a potential link between Cronobacter and Similac powdered infant formula. The 34-page report from the whistleblower has allegations of wrongdoing at the facility. They include: Falsification of records relating to testing of seals, signing verifications without adequate knowledge, failure to … [Read more...]

FDA Update on Similac Cronobacter Investigation Reveals No Match

The FDA has updated the Similac Cronobacter investigation  and reports that there is no match between the environmental samples of Cronobacter found at Abbott Nutrition's Sturgis, Michigan plant and the two patient samples the CDC received and tested. In all, four infants were sickened with Cronobacter infections after allegedly consuming powdered infant formula produced by Abbott Nutrition. Two infants who lived in Ohio died, although the FDA has not determined if Cronobacter had a role in those deaths. The FDA states, "Five environmental subsamples collected from the Sturgis, Michigan facility were positive for Cronobacter sakazakii; four were detected by the FDA and one was detected through firm-initiated testing. The positive Cronobacter sakazakii environmental samples at the … [Read more...]

CDC: Two Cronobacter Samples Not Closely Related to Swabs From Abbott

The CDC has found that two Cronobacter samples from infants are not closely related to environmental swabs that were taken by the FDA from the Abbott Nutrition facility in Michigan. Powdered infant formulas that have since been recalled were produced at that venue. This update, published on March 25, 2022, also found that bacteria from the two available samples are not closely related to each other. These conclusions come from whole genome sequencing conducted on the samples. FDA analysis is ongoing, and there is no word on whether or not samples from the other two patients have been analyzed with whole genome sequencing (WGS). The government is still recommending that parents not feed their infants recalled powdered formula made at that Michigan plant. The formula types that are … [Read more...]

Rep Krishnamoorthi Launches Inquiry Into FDA Similac Formula Response

Rep Krishnamoorthi launches inquiry into the FDA Similac powdered infant formula response after four infants were sickened and two died. Rep. Krishnamoorthi is the Chairman of the Subcommittee on Economic and Consumer Policy in the U.S. House of Representatives. A letter was sent requesting information about the FDA's alleged "delayed response" in addressing contaminated infant formula. The Chairman wrote, "FDA is tasked with protecting all Americans from life-threatening foodborne illness outbreaks, but fell short in protecting vulnerable infants from contaminated formula. FDA must do more to ensure no lives are lost, or babies sickened, due to delayed inspections and late consumer warnings." The Minnesota Department of health alerted the FDA in September 2021 that an infant's … [Read more...]

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

Analysis 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 … [Read more...]

Abbott Nutrition Form 483 Released by FDA in Cronobacter Illness Investigation

Abbott Nutrition Form 483 has been released by the FDA in the investigation of four Cronobacter illnesses linked to recalled Similac powdered infant formula. The three forms were released after inspections were conducted by the FDA at Abbott's facility in Sturgis, Michigan. All of the sick infants, who lived in Minnesota, Texas, and Ohio, are reported to have consumed powdered infant formula that was produced at that facility. The inspections were conducted on September 16 - 24, 2019, Sepatember 20 - 24, 2021, and January 31 - March 18, 2022. The notice states, "The inspectional observations in these Form 483s do not constitute final FDA determinations of whether any condition was or is in violation of the Federal Food, Drug, and Cosmetic Act or any of its implementing regulations. … [Read more...]

FDA Updates the Recalled Cronobacter Infant Formula Product List

The FDA has updated the recalled Cronobacter infant formula list with a full list of recalled products. In addition, they say that metabolic and other medical specialty infant formulas were produced at the same plant which made the recalled Similac PM 60/40, but those products were not recalled "because the FDA has determined that the risk of not having these specialty products available could significantly worsen underlying medical conditions. For many of these patients, the risk of life-threatening adverse events from restricted access to these critically needed products is likely greater than the risk from consuming products that have been produced at the facility." So far, at least four infants, who lived in Minnesota, Texas, and Ohio, have been diagnosed with Cronobacter … [Read more...]

FDA Removed a Salmonella Illness From Powdered Infant Formula Count

The FDA removed a Salmonella illness from the powdered infant formula case count, accord to an update issued for that agency's CORE Outbreak Investigation Table. The Table itself does not contain this information; it was sent in an email. Salmonella has been removed from the Pathogen column in that outbreak investigation. There are still four infants in the case count linked to Similac, EleCare, and Alimentum powdered infant formulas. Those infants are from Minnesota, Ohio, and Texas. The two infants who lived in Ohio died, although the FDA is investigating to see if Cronobacter sakazakii contributed to those deaths. Two recalls have been issued for those infant formula products. The first, on February 17, 2022, was for Similac, EleCare, and Alimentum powdered infant formula with … [Read more...]

DeLauro Wants an Investigation into FDA Handling of Infant Formula Recall

Rep. DeLauro wants an investigation into the FDA handling of infant formula monitoring and recalls, more specifically the Abbott Nutrition powdered infant formula recall associated with at least four Cronobacter illnesses. Rosa Delauro (D-CT) is the chair of the House Appropriations Committee. A letter was sent to the Inspector General of the Department of Health and Human Services, asking for her assistance in this investigation. DeLauro states, "Based on reports, I am concerned the agency acted too slowly in pulling potentially dangerous infant formula off store shelves, which may have resulted in additional illnesses and death. The delay between the September inspection and the recall raises serious questions about the FDA’s ability to adequately regulate the infant formula … [Read more...]

Expanded Similac Recall For Cronobacter Complaints Posted

The expanded Similac recall for Cronobacter complaints has been posted on the FDA recall page. At least four infants have been diagnosed with Cronobacter infections after consuming Similac, EleCare, or Alimentum powdered infant formula with specific lot numbers and expiration dates that were produced at Abbott Nutrition's Sturgis, Michigan plant. Two of those infants who lived in Ohio died, although the FDA is investigating to see if Cronobacter contributed to those deaths. The expanded Similac recall for Cronobacter complaints is for Similac PM 60/40 with lot number 27032K80 for the can and 27032K800 for the case. This recall is in addition to the lots of Similac, Alimentum, and EleCare powdered formula that were voluntarily recalled on February 17, 2022. This new recall was … [Read more...]

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