From September 1, 2019 to September 20, 2021, Abbott Nutrition received 17 consumer complaints about Similac powdered infant formula products.
Fifteen complaints are about children who tested positive for Salmonella after consuming a Similac product. One complaint referred to a baby who had been diagnosed with Cronobacter (Enterobacter) sakazakii, and another was due to an unspecified cause of death.
This information is contained in the Establishment Inspection Report (EIR) from 20 to 24 September 2021, in response to a request from the Food and Drug Administration’s Freedom of Information Act obtained by eFoodAlert.
How the complaints were handled
In response to Cronobacter’s complaint, the company reviewed its batch records and records of finished product microbiological tests. The complaint was examined by an Abbott Nutrition Medical Team insider.
The company closed the complaint that all batch records were acceptable, that there were no other consumer complaints, and that the microbiological tests were negative for C. sakazaki.
Complaints of child deaths led to a review of the batch records of the three Similac Alimentum batches. After the review was completed and it was determined that no other medical complaints or concerns were identified for the products, the company closed the complaint.
Of the 15 complaints of Salmonella, Similac Alimentum, Similac ProAdvance, Similac Spit-Up, Similac Total Comfort, Similac Advance, Similac Pro Sensitive, or Elecare for Children were children who were fed one or more batches.
15 children tested positive for Salmonella.
Again, batch record reviews were acceptable and the results of the finished product testing were negative for Salmonella.
A sample of the finished product from one of the batches involved (Similac Advance batch # 472005) was obtained from the consumer by Abbott Nutrition. The sample was visually inspected and examined in the packaging laboratory.
The company did not perform any microbiological analysis on this sample.
Abbott Nutrition’s “Standard Operating Procedures for the Treatment of Complaints”. . . Any chemical or microbial analysis of an unopened customer sample requires the approval of the AN Vice President or representative of the AN.
The EIR does not indicate whether permission was requested for microbiological analysis of the sample.
The results of Abbott’s internal tests are worrying
In addition to consumer complaints, the EIR reveals that the company found Cronobacter in two batches of finished products.
The first of these positive results was recorded by Similac Alimentum (Lot 697464), produced on September 25, 2019, one day after the FDA completed its inspection of the Abbott production facility in September 2019.
The basis for the pollution was determined to be the environment. The company imposed remedial action and destroyed the contaminated lot.
The exact cause of the second positive result, this time, was never found in the Similac Spit-Up (Lot 732675) held on June 22, 2020, according to the EIR. Several gaps were noticed in the investigation of the cause of the cause, corrective actions were imposed and the lot was destroyed.
In addition to the two Cronobacter cases in the finished products, Abbott also found Cronobacter in five environmental samples from January 2019 to August 2021. There were no Salmonella-positive environmental samples.
All positive results of Cronobacter were derived from non-contact surfaces.
In a memorandum dated February 17, 2022, Abbott acknowledged that “… evidence of Cronobacter sakazakii is found in plants in non-contact areas.”
However, FDA research recovered Cronobacter sakazakii at least as soon as it appeared to be on the touch surface, as described in the 2022/01 / 31-18 / 3/2022 Inspection Observation Report (FDA Form 483).
The explanation for the lack of positive findings of Cronobacter on surfaces in contact with the product is set out 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 performs environmental sampling of product contact surfaces and non-product contact surfaces, as well as air, water, steam, and compressed air.
Enterobacteriaceae are analyzed from samples in contact with the product and from non-contact surfaces.
Enterobacteriaceae is a family of bacteria that includes Salmonella and Cronobacter, and a total test of Enterobacteriaceae can be used in a production facility as an indicator of general health conditions.
If a non-product contact surface tested positive in an area of the plant that the company considered to be “highly cared for,” isolates were analyzed for both Salmonella and Cronobacter.
On the other hand, if a contact surface of the product was positive for Enterobacteriaceae, the company did NOT test the isolates in Salmonella or Cronobacter, rationalizing that the finished product is analyzed for both microbes.
However, in the absence of massive contamination, salmonella or Cronobacter would probably be at very low levels in the finished product, and the chances of detecting these contaminants would be like the same number appearing twice in a row. roulette.
By choosing not to test positive contact surfaces for Cronobacter or Salmonella Enterobacteriaceae products, the company lost the opportunity to address a serious issue.
The FDA is not innocent
Abbott Nutrition’s two-year inspections at its production plant in Sturgis, Michigan.
At the time, the United States – in fact, the whole world – was being hit by the Covid-19 pandemic.
When the FDA returned to Abbott, the company’s Covid-19 protection program had to report the planned inspection to the agency, something that had not happened in the past.
Although the company had a four-day notice that it could “tidy up” the FDA’s visit, the inspection team found several issues that were still relevant, which were specified on the company’s Inspection Observation Form (FDA Form 483). end of inspection.
But one key observation was missing from the list:
No mention was made of the two batches of finished products that tested positive for Cronobacter sakazakii from the previous inspection, nor of the results of environmental tests in favor of Cronobacter.
These observations were incorporated into Model 483 issued at the end of January-March 2022.
According to the September 2021 EIR, the two-person FDA inspection team did not conduct any environmental sampling during the visit, even after learning of the positive results of Cronobacter. Two completed batch samples were taken for nutrient analysis and two for microbiological analysis.
Seven months after the FDA received its first report of a child infected with Cronobacter and almost four months after the agency began an in-depth inspection of Abbott Nutrition’s production facilities, several questions remain:
- Given what the FDA learned about finished product samples and environmental samples from the Abbott facility, which is Cronobacter positive in September 2021, why did it take more than four months for the agency to begin another inspection after receiving disease reports?
- Why didn’t the FDA inspectors respond more strongly to Cronobacter’s positive results by writing a list of Inspection Observations at the end of the September 2021 inspection?
- Would Abbott have found and solved the contamination problem earlier if he had tested surfaces related to the Cronobacter product instead of relying on finished product testing?
- Since Cronobacter (unlike Salmonella) is not a “new” disease in 49 states, how many more cases of Cronobacter have been reported in children?
- Why was it necessary until February 17, 2022, when the public became aware of the situation?