– CONTRIBUTED ANALYSIS –
Editor’s note: This column was originally published in eFoodAlert and is republished here with the author’s permission.
Between Sept. 1, 2019, and Sept. 20, 2021, Abbott Nutrition received 17 consumer complaints regarding multiple Similac powdered infant formula products.
Fifteen of the complaints related to infants testing positive for Salmonella after consuming a Similac product. One complaint cited an infant who was diagnozed with Cronobacter (Enterobacter) sakazakii, and one was as the result of an infant death from an unspecified cause.
This information is contained in the Sept. 20-24, 2021, Establishment Inspection Report (EIR), obtained by eFoodAlert from the Food and Drug Administration in response to a Freedom of Information Act request.
How the complaints were handled
In response to the Cronobacter complaint, the company reviewed its batch records and its finished product microbiological testing records. The complaint was reviewed by an internal Abbott Nutrition Medical Team.
The firm closed the complaint after determining that all batch records were acceptable, that there were no other consumer complaints, and that microbiological testing was negative for C. sakazakii.
The infant death complaint triggered a batch record review for three lots of Similac Alimentum. After completing the review and determining that no other complaints or medical concerns had been identified for the products, the company closed the complaint.
The 15 Salmonella complaints involved infants who had been fed one or more batches of Similac Alimentum, Similac ProAdvance, Similac Spit-Up, Similac Total Comfort, Similac Advance, Similac Pro Sensitive or Elecare for Infants.
All 15 of the infants tested positive for Salmonella.
Once again, the batch record reviews came back acceptable, and finished product testing results were negative for Salmonella.
A finished product sample of one of the implicated batches (Similac Advance lot #472005) was obtained by Abbott Nutrition from the consumer. The sample was subjected to a visual exam, and the container was examined in the packaging lab.
The company did not conduct any microbiological tests on this sample.
Abbott Nutrition’s “Standard Operating Procedure for Handling Complaints” specifies that “. . . any chemical or microbial testing of an unopened customer sample requires the approval of the AN Vice President Quality or delegate.”
The EIR does not state whether approval was sought to carry out microbiological tests on the sample.
Abbott’s internal test results raise concerns
In addition to the consumer complaints, the EIR also reveals that the company had found Cronobacter in two batches of finished product.
The first of these positive results was recorded for Similac Alimentum (Batch 697464), produced on Sept. 25, 2019, just one day after the completion of the FDA’s September 2019 inspection of Abbott’s production facility.
The root cause of the contamination was determined to be environmental. The company implemented correction actions and destroyed the contaminated batch.
The specific root cause for the second positive result, this time in Similac Spit-Up (Batch 732675), produced on June 22, 2020, was never found, according to the EIR. Several deficiencies were noted during the root cause investigation, corrective actions were implemented, and the batch was destroyed.
In addition to the two instances of Cronobacter in finished products, Abbott also found Cronobacter in five environmental samples between January 2019 and August 2021. There were no Salmonella-positive environmental samples.
All of the Cronobacter-positive results were from non-product contact surfaces.
In its Feb.17, 2022, recall notice, Abbott acknowledged “…evidence of Cronobacter sakazakii in the plant in non-product contact areas.”
Yet the FDA investigation recovered Cronobacter sakazakii from at least one swab of what appears to be a contact surface, as described in the 1/31/2022-3/18/2022 Inspectional Observations report (FDA Form 483).
The explanation for the absence of Cronobacter-positive findings on product contact surfaces is revealed in the description of Abbott Nutrition’s environmental sampling procedures as reported in the September 2021 EIR.
According to the description of Abbott Nutrition’s environmental sampling program, the company conducts environmental sampling of product contact surfaces and non-product contact surfaces, as well as air, water, steam and compressed air.
Swab samples from product contact surfaces and non-product contact surfaces are tested for Enterobacteriaceae.
Enterobacteriaceae is a family of bacteria that includes both Salmonella and Cronobacter, and a test for total Enterobacteriaceae may be used as an indicator of general sanitary conditions in a production facility.
If a non-product contact surface produced a positive result in an area of the plant that was considered “high care” by the company, the isolates were analyzed for both Salmonella and Cronobacter.
On the other hand, if a product contact surface was positive for Enterobacteriaceae, the company did NOT test the isolates for Salmonella or Cronobacter, rationalizing that the finished product is analyzed for both microbes.
However, except in the event of massive contamination, Salmonella or Cronobacter most likely would be present at very low levels in the finished product, and the chances of detecting these contaminants would be akin to having the same number come up twice in a row on a roulette wheel.
By choosing not to test Enterobacteriaceae-positive product contact surfaces for Cronobacter or Salmonella, the company missed an opportunity to head off a serious problem.
FDA not blameless
There was a two year gap between inspections of Abbott Nutrition’s production plant in Sturgis, Michigan.
During this time, the United States — indeed, the entire world — was reeling from the Covid-19 pandemic.
When the FDA returned to Abbott, the company’s Covid-19 protection program required that the agency give advance notice of their planned inspection — something that had not been the case in the past.
Although the company had four days notice during which they could “tidy up” in anticipation of the FDA visit, the inspection team still found several issues of note, which were detailed in the Inspectional Observations form (FDA Form 483) provided to the company at the end of the inspection.
But one key observation was missing from the list:
There was no mention of the two finished product batches that had tested positive for Cronobacter sakazakii since the previous inspection, nor of the Cronobacter-positive environmental test results.
These observations were included instead on the Form 483 issued at the end of the January-March 2022 inspection.
According to the September 2021 EIR, the two-person FDA inspection team did not carry out any environmental sampling during the course of their visit, even after learning of the Cronobacter-positive results. Two finished product batches were sampled for nutrient analysis and two for microbiological analysis.
Unanswered questions
Seven months after FDA received the first report of an infant infected with Cronobacter and nearly four months after the agency initiated its in-depth inspection of Abbott Nutrition’s production facility, several questions remain:
- In view of what the FDA learned in September 2021 regarding Cronobacter-positive environmental and finished product samples at the Abbott facility, why did it take more than four months for the agency to initiate another inspection after receiving the first of the illness reports?
- Why did the FDA inspectors not respond more forcefully to those Cronobacter-positive results when writing up the list of Inspectional Observations at the completion of their September 2021 inspection?
- Would Abbott have discovered and addressed its contamination problem sooner if it had tested product-contact surfaces for Cronobacter instead of relying upon finished product tests?
- As Cronobacter (unlike Salmonella) is not a “reportable” disease in 49 states, how many additional cases of Cronobacter in infants have gone unreported?
- Why did it take until Feb. 17, 2022, before the public was made aware of the situation?
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