In the calendar year 2021, Abbott Laboratories, the parent company of Abbott Nutrition, spent almost $2.3 BILLION to repurchase shares of its stock.

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

In 2020, Abbott Laboratories’ net profits were in excess of $7 BILLION, an increase of more than 57% over the net profits of the year before.

Between September 2019 and January 2022, while the corporation’s profits soared and Abbott Laboratories plowed billions of dollars into a stock buy-back program, maintenance and quality control issues at Abbott Nutrition’s Sturgis plant 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 Establishment Inspection Report, obtained by eFoodAlert in response to a Freedom of Information Act request.

Between September 2018 and September 2019, both the FDA and the company received several complaints of illnesses among babies who had been fed a Similac infant formula product. These included:

• A report from a Pediatric Nurse Practitioner that five babies under the practitioner’s care had suffered from projectile vomiting after consuming Similac Sensitive Infant Formula (multiple batch codes).
• An infant diagnosed with Enterobacter (Cronobacter) sakazakii after consuming three different infant formula products, two of which were Similac products. The infant was treated with antibiotics and recovering.
• A baby was infected with Salmonella after consuming a specific batch code Similac Total Comfort infant formula.
• An infant consumed Similac Sensitive infant formula and developed high temperature and vomiting. The infant was diagnosed with Salmonella.
• A male baby tested positive for Salmonella after consuming a batch of Similac Sensitive infant formula.
• A baby possibly infected with Salmonella after having been fed two different batches of Similac Sensitive.
• A baby being fed Similac Advance formula 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 the results of microbiological tests conducted at the time of manufacture.

In some cases, the company conducted microbiological tests of retained samples from the indicated batches, with uniformly negative results.

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

In addition to the consumer complaints, the company’s own lab found Cronobacter in a sample of Alimentum Advance Powder on August 5, 2019, during the course of 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 firm identified the root cause as being “…due to a non-routine intervention.”

According to the company’s records, the firm identified and implemented corrective actions, and designated the contaminated batch for destruction.

Environmental monitoring results from after the “non-routine intervention” showed two fails followed by two pass results (ie., Cronobacter-negative) on follow-up.

The 2019 FDA inspection

The FDA’s 2018 inspection resulted in the Sturgis facility receiving a clean bill of health. In fact, all of the prior inspections of this location from 2011 through 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” which was conducted as part of the Infant Formula Program and Medical Foods Program.

However, even with the history of complaints, the agency conducted only a superficial lab investigation. FDA inspectors obtained samples of two finished products to conduct nutrient analysis and microbiological tests.

Both finished products yielded 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 included any raw material, in-process, or environmental sampling.

The visual inspection observations included in the EIR indicate a production plant that appeared to be in good repair, with proper attention given to maintenance and sanitation.

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

The inspectors reviewed the company’s maintenance records, and noted repairs to small cracks and pitted areas along the production lines and on the exterior and inside of dryers.

The only significant negative observation was an error in sampling finished product for microbiological testing. A technician was seen to draw 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 to some other reason, there was no annual inspection of Abbott Nutrition’s Sturgis location in 2020.

When the FDA inspectors returned to Sturgis in September 2021, they found a very different situation. At the completion of their five-day inspection, they issued a formal list of Inspectional Observations (FDA Form 483).

• Standing water in multiple locations
• Processing operator not sanitizing or changing gloves after touching non-food contact surfaces, before going on to touch food contact surfaces
• Lack of calibration of flow meters, pressure sensors and a flow sensor on the product line
• Inadequate frequency of temperature monitoring for a pasteurizer, even though temperature was identified as a Critical Control Point for the product in question.

The Form 483 leaves multiple questions unanswered:

• What consumer complaints were lodged with either the FDA or the company during the two years between inspections?
• Did the FDA conduct 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 “Inspectional Observation?”
• Were the inspectors aware at the time they were on location that the FDA had received a Cronobacter sakazakii illness report linked to an Abbott Nutriton product?

Answers to at least some of these questions should be contained 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 report of the September 2021 inspection, it is clear from the contents of the Form 483 issued at the completion of the January-March 2022 inspection that conditions in the Sturgis plant had deteriorated significantly since 2019.

• Environmental samples collected near the start of the FDA inspection revealed the presence of Cronobacter sakazakii in multiple locations. Whole genome sequencing determined that five different strains of the pathogen were present in the plant environment.
• Between the end of the September 2019 inspection and February 20, 2022, Abbott’s own testing activities documented at least eight instances of Cronobacter contamination in the environment and two instances of Cronobacter in finished products.
• A review of Work Orders revealed multiple instances of water leaks, including one location that was the source of three separate leaks over the course of a year.
• A total of 310 “water events” documented by the company between January 1, 2020 and February 1, 2022, including water leaks, moisture and condensation in dry powdered infant formula production areas. These events were not associated with routine clean-in-place equipment cycles.
• A history of internal deterioration of dryers dating back to September 2018, including multiple instances of pits and cracks inside the main chambers of at least two dryers.
• Inadequate follow-up of consumer complaints received by FDA beginning in September 2021 regarding Cronobacter sakazakii and Salmonella illnesses potentially associated with three different Similac dry infant formula products.

How was this allowed to happen?

Both Abbott Nutrition and the FDA have a lot to answer for.

Ever since a baby died from a Cronobacter sakazakii infection in Tennessee in 2001, the FDA has repeatedly claimed that ensuring the safety of infant formulas was a high priority for the agency.

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

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

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

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

Learn more about Cronobacter sakazakii and other foodborne disease outbreaks in TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures, now available in digital, print and audiobook editions.