What price benefits? – eFoodAlert

During the calendar year 2021, Abbott Laboratoriesthe parent company of Abbott Nutrition, spent nearly $2.3 billion to repurchase shares of its stock.

This is in addition to $403 million spent for the same purpose in 2020, $718 million in 2019 and $238 million in 2018.

In 2020, Net Profits of Abbott Laboratories exceeded $7 billion, an increase of more than 57% over net profits the previous year.

Between September 2019 and January 2022, as the company’s profits soared and Abbott Laboratories funneled billions of dollars into a stock buyback program, maintenance and quality control issues at the plant Abbott Nutrition from Sturgis have snowballed.

Early warnings

The early warning signals were evident during the FDA’s 2019 annual inspection of the company’s manufacturing facility, as documented in the facility’s inspection report, obtained by eFoodAlert in response to a Freedom of Information Act request.

Between September 2018 and September 2019, the FDA and the company received several complaints of illnesses in babies fed Similac infant formula. These included:

  • A report from a pediatric nurse practitioner that five babies in his care suffered from projectile vomiting after consuming Similac Sensitive Infant Formula (multiple lot codes).
  • An infant diagnosed with Enterobacter (Cronobacter) sakazakii after consuming three different infant formulas, two of which were Similac products. The infant was treated with antibiotics and recovering.
  • A baby was infected with Salmonella after consuming Similac Total Comfort lot-specific infant formula.
  • An infant consumed Similac Sensitive infant formula and developed a high temperature and vomiting. The infant was diagnosed with Salmonella.
  • A male baby has tested positive for Salmonella after consuming one batch of Similac Sensitive infant formula.
  • A baby may be infected with Salmonella after receiving two different lots of Similac Sensitive.
  • A baby fed Similac Advance formula has died. The cause of death was unknown

The company responded to all of these complaints by conducting reviews of its records for similar complaints (none found), reviewing batch records and microbiological test results performed at the time of manufacture.

In some cases, the company has performed microbiological testing on retained samples from the indicated lots, with consistently negative results.

In response to the Cronobacter complaint, Abbott also performed microbiological testing on the consumer’s opened product, with negative results.

In addition to consumer complaints, the company’s own lab found Cronobacter in a sample of Alimentum Advance Powder on August 5, 2019, during routine finished product testing activities.

In response, Abbott quarantined the Cronobacter– positive batch, in addition to the batches produced immediately before and after the contaminated batch.

After investigating the source of the contamination, the company identified the root cause as “…due to non-routine intervention.”

According to company records, the company identified and implemented corrective actions, and designated the contaminated lot for destruction.

Environmental monitoring results after “non-routine intervention” showed two failures followed by two positives (i.e., Cronobacter-negative) during follow-up.

The 2019 FDA inspection

The 2018 FDA inspection resulted in the Sturgis facility receiving a clean bill of health. In fact, all previous inspections of this location from 2011 to 2018 were without adverse observations, according to the FDA inspection database.

The 2019 Establishment Inspection Report (EIR) describes the FDA visit as a “comprehensive surveillance inspection” that was conducted for the infant formula program and the medical food program.

However, even with the complaint history, the agency conducted only a cursory lab investigation. FDA inspectors obtained samples of two finished products to perform nutritional analysis and microbiological testing.

Both finished products gave negative test results for both Cronobacter and Salmonella.

Despite Abbott’s acknowledgment of having found Cronobacter in a finished product and in the environment, the inspection did not include raw material, in-process or environmental sampling.

Visual inspection observations included in the EIR indicate a production plant that appeared to be in good condition, with appropriate attention paid to maintenance and sanitation.

There was no evidence of insect or rodent infestation, and no birds were flying in the production or warehouse areas.

Inspectors reviewed the company’s maintenance records and noted repairs to small cracks and pitting along the production lines and outside and inside the dryers.

The only significant negative observation was an error in sampling the finished product for microbiological testing. A technician was seen taking only 30 samples from a production lot instead of the 60 samples required under the sampling plan.

The two-year gap

Whether due to the Covid-19 pandemic or another reason, there was no annual inspection of the Abbott Nutrition site in Sturgis in 2020.

When FDA inspectors returned to Sturgis in September 2021, they discovered a very different situation. At the end of their five-day inspection, they released an official list of inspection observations (FDA Form 483).

  • Standing water in several places
  • Processor does not sanitize or change gloves after touching non-food contact surfaces, before continuing to touch food contact surfaces
  • Lack of calibration of flowmeters, pressure sensors and a flow sensor on the product range
  • Inadequate frequency of temperature monitoring for a pasteurizer, even though temperature has been identified as a critical control point for the product in question.

Form 483 leaves several questions unanswered:

  • What consumer complaints were filed with the FDA or the company in the two years between inspections?
  • Did the FDA perform any environmental, raw material, or finished product testing as part of this inspection?
  • What other observations were noted during the inspection that did not rise to the level of a formal “inspection observation”?
  • Did the inspectors know, when they were there, that the FDA had received a Cronobacter sakazakii Abbott Nutriton product related illness report?

Answers to at least some of these questions should be included in the full establishment inspection report. eFoodAlert has requested, but has not yet received, a copy of the full report.

Even in the absence of the full September 2021 inspection report, it is clear from the contents of the Form 483 issued at the end of the January-March 2022 inspection that conditions at the Sturgis plant had improved. significantly deteriorated since 2019.

  • Environmental samples taken near the start of the FDA inspection revealed the presence of Cronobacter sakazakii in several places. Whole genome sequencing determined that five different strains of the pathogen were present in the plant’s environment.
  • Between the end of the September 2019 inspection and February 20, 2022, Abbott’s own testing operations documented at least eight cases of Cronobacter contamination in the environment and two cases of Cronobacter in finished products.
  • A review of work orders revealed several instances of water leaks, including one location that was the source of three separate leaks in one year.
  • A total of 310 “water events” documented by the company between January 1, 2020 and February 1, 2022, including water leaks, humidity and condensation in the production areas of dry powdered infant formula. These events were not associated with routine equipment clean-in-place cycles.
  • A history of internal dryer deterioration dating back to September 2018, including multiple instances of pitting and cracking inside the main chambers of at least two dryers.
  • Insufficient follow-up of consumer complaints received by the FDA from September 2021 regarding Cronobacter sakazakii and Salmonella diseases potentially associated with three different Similac dry infant formulas.

How could this have happened?

Abbott Nutrition and the FDA have a lot to answer.

Since a baby died of a Cronobacter sakazakii infection in Tennessee in 2001, the FDA repeatedly asserted that infant formula safety was a priority for the agency.

Yet the agency let two years elapse between inspections of Abbott Nutrition’s more than sixty-year-old production facility in Sturgis, Michigan.

This failure, however, does not excuse Abbott’s lack of care.

Food manufacturers–especially those serving vulnerable populations such as infants– are legally, morally and ethically bound to ensure the safety of all their products.

There is no excuse that Abbott abrogated its responsibilities to its customers. Certainly, the company cannot cite poverty as a reason for having neglected to properly maintain its production tool and its manufacturing environment.

Learn more about Cronobacter sakazakii and other foodborne disease outbreaks in BLEACHED. From farm to plate, fifty years of food safety failuresnow available in digital, print and audiobook edition.

“Reads like a real crime novel” – Food Safety News