Abbott Nutrition: The gathering storm


Editor’s word: This column was initially printed in eFoodAlert and is republished right here with the writer’s permission.

Between Sept. 1, 2019, and Sept. 20, 2021, Abbott Nutrition obtained 17 client complaints relating to a number of Similac powdered toddler formulation merchandise.

Fifteen of the complaints associated to infants testing optimistic for Salmonella after consuming a Similac product. One criticism cited an toddler who was diagnozed with Cronobacter (Enterobacter) sakazakii, and one was as the results of an toddler demise from an unspecified trigger.

This data is contained within 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 had been dealt with
In response to the Cronobacter criticism, the corporate reviewed its batch information and its completed product microbiological testing information. The criticism was reviewed by an inside Abbott Nutrition Medical Team.

The agency closed the criticism after figuring out that every one batch information had been acceptable, that there have been no different client complaints, and that microbiological testing was detrimental for C. sakazakii.

The toddler demise criticism triggered a batch document evaluation for 3 numerous Similac Alimentum. After finishing the evaluation and figuring out that no different complaints or medical issues had been recognized for the merchandise, the corporate closed the criticism.

The 15 Salmonella complaints concerned infants who had been fed a number of 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 examined optimistic for Salmonella.

Once once more, the batch document opinions got here again acceptable, and completed product testing outcomes had been detrimental for Salmonella.

A completed product pattern of one of many implicated batches (Similac Advance lot #472005) was obtained by Abbott Nutrition from the patron. The pattern was subjected to a visible examination, and the container was examined within the packaging lab.

The firm didn’t conduct any microbiological checks on this pattern.

Abbott Nutrition’s “Standard Operating Procedure for Handling Complaints” specifies that “. . . any chemical or microbial testing of an unopened buyer pattern requires the approval of the AN Vice President Quality or delegate.”

The EIR doesn’t state whether or not approval was sought to hold out microbiological checks on the pattern.

Abbott’s inside take a look at outcomes increase issues
In addition to the patron complaints, the EIR additionally reveals that the corporate had discovered Cronobacter in two batches of completed product.

The first of those optimistic outcomes was recorded for Similac Alimentum (Batch 697464), produced on Sept. 25, 2019, simply someday after the completion of the FDA’s September 2019 inspection of Abbott’s manufacturing facility.

The root reason behind the contamination was decided to be environmental. The firm carried out correction actions and destroyed the contaminated batch.

The particular root trigger for the second optimistic outcome, this time in Similac Spit-Up (Batch 732675), produced on June 22, 2020, was by no means discovered, in line with the EIR. Several deficiencies had been famous through the root trigger investigation, corrective actions had been carried out, and the batch was destroyed.

In addition to the 2 situations of Cronobacter in completed merchandise, Abbott additionally discovered Cronobacter in 5 environmental samples between January 2019 and August 2021. There had been no Salmonella-positive environmental samples.

All of the Cronobacter-positive outcomes had been from non-product contact surfaces.

In its Feb.17, 2022, recall discover, Abbott acknowledged “…proof of Cronobacter sakazakii within the plant in non-product contact areas.”

Yet the FDA investigation recovered Cronobacter sakazakii from at the least one swab of what seems to be a contact floor, as described within the 1/31/2022-3/18/2022 Inspectional Observations report (FDA Form 483).

The rationalization for the absence of Cronobacter-positive findings on product contact surfaces is revealed within the description of Abbott Nutrition’s environmental sampling procedures as reported within the September 2021 EIR.

According to the outline of Abbott Nutrition’s environmental sampling program, the corporate conducts environmental sampling of product contact surfaces and non-product contact surfaces, in addition to air, water, steam and compressed air.

Swab samples from product contact surfaces and non-product contact surfaces are examined for Enterobacteriaceae.

Enterobacteriaceae is a household of micro organism that features each Salmonella and Cronobacter, and a take a look at for complete Enterobacteriaceae could also be used as an indicator of common sanitary circumstances in a manufacturing facility.

If a non-product contact floor produced a optimistic lead to an space of the plant that was thought of “excessive care” by the corporate, the isolates had been analyzed for each Salmonella and Cronobacter.

On the opposite hand, if a product contact floor was optimistic for Enterobacteriaceae, the corporate did NOT take a look at the isolates for Salmonella or Cronobacter, rationalizing that the completed product is analyzed for each microbes.

However, besides within the occasion of large contamination, Salmonella or Cronobacter most definitely could be current at very low ranges within the completed product, and the possibilities of detecting these contaminants could be akin to having the identical quantity come up twice in a row on a roulette wheel.

By selecting to not take a look at Enterobacteriaceae-positive product contact surfaces for Cronobacter or Salmonella, the corporate missed a possibility to move off a major problem.

FDA not innocent
There was a two yr hole between inspections of Abbott Nutrition’s manufacturing plant in Sturgis, Michigan.

During this time, the United States — certainly, your entire world — was reeling from the Covid-19 pandemic.

When the FDA returned to Abbott, the corporate’s Covid-19 safety program required that the company give advance discover of their deliberate inspection — one thing that had not been the case previously.

Although the corporate had 4 days discover throughout which they might “tidy up” in anticipation of the FDA go to, the inspection staff nonetheless discovered a number of problems with word, which had been detailed within the Inspectional Observations type (FDA Form 483) offered to the corporate on the finish of the inspection.

But one key commentary was lacking from the listing:

There was no point out of the 2 completed product batches that had examined optimistic for Cronobacter sakazakii because the earlier inspection, nor of the Cronobacter-positive environmental take a look at outcomes.

These observations had been included as a substitute on the Form 483 issued on the finish of the January-March 2022 inspection.

According to the September 2021 EIR, the two-person FDA inspection staff didn’t perform any environmental sampling through the course of their go to, even after studying of the Cronobacter-positive outcomes. Two completed product batches had been sampled for nutrient evaluation and two for microbiological evaluation.

Unanswered questions
Seven months after FDA obtained the primary report of an toddler contaminated with Cronobacter and practically 4 months after the company initiated its in-depth inspection of Abbott Nutrition’s manufacturing facility, a number of questions stay:

  • In view of what the FDA discovered in September 2021 relating to Cronobacter-positive environmental and completed product samples on the Abbott facility, why did it take greater than 4 months for the company to provoke one other inspection after receiving the primary of the sickness stories?
  • Why did the FDA inspectors not reply extra forcefully to these Cronobacter-positive outcomes when writing up the listing of Inspectional Observations on the completion of their September 2021 inspection?
  • Would Abbott have found and addressed its contamination downside sooner if it had examined product-contact surfaces for Cronobacter as a substitute of relying upon completed product checks?
  • As Cronobacter (in contrast to Salmonella) shouldn’t be a “reportable” illness in 49 states, what number of extra circumstances of Cronobacter in infants have gone unreported?
  • Why did it take till Feb. 17, 2022, earlier than the general public was made conscious of the scenario?

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