Months before the FDA opened an investigation into four Cronobacter illnesses and two deaths among infants who consumed Similac, a whistleblower alerted senior agency officials to food safety violations at Abbott Nutrition’s plant in Sturgis, MI where the powdered infant formula was made.
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House Appropriations Committee Chair Rosa DeLauro (D-CT) released the 34-page document, compiled by a former Abbott employee, at an Agriculture Appropriations Subcommittee meeting yesterday. It outlines what DeLauro calls a “damning list of allegations of wrongdoing at this factory, including:
- Falsification of records relating to testing of seals, signing verifications without adequate knowledge, failure to maintain accurate maintenance records, shipping packages with fill weights lower than what was on the label, and more;
- Releasing untested infant formula;
- Hiding information during a 2019 FDA audit;
- Lax practices associated with clean in place procedures;
- Lack of traceability of the product;
- Failure to take corrective measures once the company knew their testing procedures were deficient;
- An atmosphere of retaliation against any employee who raised concerns about company practices.”
The document was given to multiple high-ranking U.S. Food and Drug Administration (FDA) officials on October 20, 2021, DeLauro said. (That’s about one month after FDA was informed by the Minnesota Department of Health that an infant who had consumed a Similac product developed a Cronobacter infection.) But FDA didn’t interview the whistleblower until late December 2021, according to DeLauro. By that point, two more Cronobacter illnesses, one of them fatal, had been reported among infants who consumed Similac.
Details from the Whistleblower’s Report
Falsification of Records Relating to Testing of Seals
According to the document, a persistent problem encountered at the plant was that the powder would “become enmeshed in the seam thereby jeopardizing the integrity of the seal and product safety.” Rather than finding a solution to the problem, plant managers decided to test empty cans instead of sealed cans containing baby formula. “Performing seam checks on empty cans was the only way to achieve passing results without finding powder in the seam. Management at the Sturgis site directed that the checks be performed in this manner,” the document states.
Releasing Untested Infant Formula
Abbott’s poor maintenance and upkeep of equipment (also noted in an FDA inspection report) led to pitting and holes in the flow pipes making it difficult to adequately clean them and therefore creating an opportunity for bacteria to grow, according to the document.
“Prior to the 2019 FDA audit, management authorized the release of infant formula that tested positive for micros. The batch of infant formula in question was the batch that had triggered the internal investigations into the product flow pipes and the investigation into the spray balls. This episode was generally referred as “the micro batches” at the Sturgis site. Since the micros were discovered during the standard batch testing (10 samples pulled evenly throughout the production of the batch, not including the first and last can produced),51 15 additional samples were taken and tested. Of these additional samples, multiple samples tested positive for micros. At that point, the decision was not made to destroy the entire batch. Instead, a time code removal was performed.52 Management decided to add so many minutes prior to and following each timeframe to “ensure” that they had eliminated all the product with micros. However, once the product was culled out, an additional set of testing was not performed to provide evidence that all the micropositive product was captured and destroyed.53 The infant formula was released commercially without supporting documentation to suggest it was compliant and safe for consumption.54”
Hiding Information During FDA Audit
The whistleblower alleges that prior to the FDA’s 2019 inspection, managers at the plant was nervous that FDA would discover what had happened with the micro batches and may have culled some records before turning them over to the FDA for review. One manager said she was “amazed that the FDA was unable to discover what occurred with the micro batches,” the document states.
Lack of Clean-in-Place Measures
From the document: “At the Sturgis site, there is no requirement for those performing the CIP work to sign and date any document verifying the performance of the work. No review or enforcement takes place by QS or anyone at the Sturgis site. If an operator is not inclined to sign the CIP checklist, no one is held accountable. The checklists are maintained by each department and are not part of the batch records.”
Lack of Traceability
A faulty pallet labeler and management’s preference for paper records create barriers to traceability, according to the document.
“The Sturgis site has had significant issues regarding the traceability of its products. QS Sturgis frequently received notification from its warehouse that pallets were found to be either mislabeled or not labeled. Often the batch to which the pallet belonged had already been released and shipped. The Sturgis site uses an automated pallet labeler. The labeler is supposed to be able to read the pallet, print a label with the correct batch-specific information, and apply the label to the pallet. However, the labeler did not always work properly.”
The whistleblower also states, “the continued reliance on paper records at the Sturgis site raises questions, especially with the conversion to electronic records being budgeted. For reasons not entirely transparent, the proposed conversion has been repeatedly deferred. One reason volunteered by one member of management to the Complainant is that electronic records would make the Sturgis site more accountable to others at the division and corporate level.”
Failure to Take Corrective Measures
The whistleblower said he was responsible for “a testing procedure relating to the export of product that was widely known to be prone to lead to mistakes by highly competent employees.” In 2020, he raised concerns about the efficacy of the testing procedure and suggested steps that could be taken to address the significant shortcomings of the procedure. No corrective measures were taken.
Atmosphere of Retaliation
According to the document, employees at the Sturgis plant do not feel free to raise concerns because it is “a workplace where fear of retaliation is palpable.”
FDA Announces Abbott Will Perform Additional Testing on Stored Batches
Between September 2021 and January 2022, four Cronobacter illnesses and fatalities were reported among infants who had consumed various kinds of Similac powdered infant formula. The Similac products and other powdered infant formulas were all produced at Abbott Nutrition’s Sturgis, MI facility where FDA inspectors found multiple food safety violations and multiple environmental swabs were positive for Cronobacter.
On February 17, 2022, the FDA advised consumers to avoid the purchase or use of these powdered infant formula products. Later that day Abbott issued a recall. And batches of all products that had been produced were stored.
In late March, the Centers for Disease Control and Prevention (CDC) announced that the Cronobacter strains found at the plant did not match “the two available patient samples.” Since then, the CDC and FDA have maintained that their investigations are still ongoing but no updates have been added. Until today, when the FDA announced that “Abbott has committed to completing enhanced testing of stored product batches prior to making release determinations.”
Meanwhile, DeLauro stated that she has “already requested that the HHS Inspector General look into this.”
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