The presence of Cronobacter sakazakii in Abbott Nutrition’s Sturgis, Michigan, production facility dates back to at least September 2019, according to information contained in an Inspection Observation report (FDA Form 483) released today by the US Food and Drug Administration (FDA).

The report details a ten-page long list of observations documented by a team of eleven FDA investigators during an inspection that lasted from January 31, 2022 to March 18, 2022.

The inspection was initiated in response to a series of four complaints of infant illnesses and death following consumption of powdered infant formula manufactured in the Sturgis facility.

Cronobacter sakazakii is an opportunistic pathogen, affecting mainly newborns, and causes neonatal necrotizing enterocolitis and neonatal meningitis. In older infants, children and adults, it can cause sepsis and/or respiratory illness. Symptoms in newborns include fever, rapid heart rate, seizures and other neurological abnormalities.

Product Recall

On February 17, 2022, Abbott initiated a recall of multiple Similac, Alimentum, or EleCare powdered infant formulas. The recall notice includes a link to the company website, where a complete list of recalled products can be found.

The recalled infant formula was distributed nationwide across the United States and also exported to multiple countries around the world, including: Australia, Bahrain, Barbados, Bermuda, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Guam, Guatemala, Hong Kong, India, Indonesia, Israel, Jordan, Kuwait, Lebanon, Malaysia, Mexico, New Zealand, Oman, Peru, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, Sudan, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam ANI South.

What FDA Discovered

During the course of their in-depth inspection, the FDA’s investigation team documented multiple issues of concern, among which were:

• Presence of Cronobacter sakazakii on environmental surfaces in the packaging room. The sample was collected while a product was being packaged.
• Presence of Cronobacter sakazakii on the floor in the immediate vicinity of a dryer.
• Presence of Cronobacter sakazakii in a sample of infant formula tested by the company in September 2019.
• Presence of Cronobacter sakazakii in a sample of infant formula tested by the company in June 2020.
• Water leaking from a dryer inlet and dripping from the valves onto the floor. Company work order documents indicated prior problems with this same inlet in February 2021, November 2021 and again on January 21, 2022.
• Standing water in multiple production areas.
• Lack of validation of the dry-out step at the end of the dryer cleaning cycle, resulting in a risk that water would remain inside the dryer at the end of the cleaning cycle.
• A history of internal deterioration of the firm’s dryers dating back to 2018, including six instances of cracks and pits in the main chamber of two different dryers and ten cracked braces for one of the dryers.
• Inadequate investigation of root causes of the four consumer complaints relating to illness reports received by the FDA. These four complaints were each asssociated with a different Abbott product.
• Inadequate attention by employees and contractors to the wearing of necessary protective apparel.

In addition to the evidence of inadequate maintenance and sanitation, the inspection report contains observations appear to directly contradict statements made in Abbott’s Voluntary Recall Notice.

Specifically, Abbott stated that the company “…found evidence of Cronobacter sakazakii in the plant in non-product contact areas.” Yet the FDA recovered the microbe from a scoop hopper used to feed scoops, “…which are placed directly inside infant formula containers and contact product.”

Also, Abbott claimed that, “…retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii.”

But the FDA investigators reported that the company’s Medical Safety and Surveillance team did not request that retain samples be tested for the production lot associated with the infant death as of January 31, 2022 (the day the investigators began their inspection).

A History Lesson

As previously reported, the FDA had conducted twenty-seven prior inspections of Abbott’s production facility since 2008. Twenty-four of the twenty-seven inspections resulted in the company’s operations receiving a clean bill of health.

In 2019, the FDA investigation team noted just one deviation during its routine inspection, observing that the firm collected only thirty samples of a production batch for Salmonella testing instead of the specified sixty samples.

Two years elapsed before the FDA conducted its next inspection. In September 2021, a team of two investigators reviewed the Sturgis plant’s operations over a four-day period. They found standing water in multiple locations, sanitation and product-handling lapses, and inadequate temperature monitoring for a pasteurizer.

The September 2021 inspection was carried out after the FDA had received the first complaint of infant illness associated with an Abbott product. The agency has offered no explanation or reason for the more than four month delay between receipt of the first complaint and initiation of an in-depth investigation of the production facility.

According to the CDC, four infants have been infected by Cronobacter sakazakii after consuming a powdered infant formula manufactured by Abbott Nutrition. All four of the infants were hospitalized and two of them have died.

The CDC has received additional reports of possible Cronobacter infections in infants and is conducting investigations to determine whether these may also be associated with this outbreak.

What Consumers Need to Know

• The first symptom of Cronobacter infection in infants (0–1 year old) is usually a fever, accompanied by poor feeding, excessive crying, or very low energy. Some infants may also have seizures. Infants with these symptoms should be seen by a medical provider as soon as possible.
• Cronobacter germs can cause a dangerous blood infection (sepsis) or make the linings surrounding the brain and spinal cord swell (meningitis). Infections in infants usually occur in the first days or weeks of life. Infants 2 months of age and younger are most likely to develop meningitis if they are infected with Cronobacter.
• Visit the FDA’s consumer advisory page to access a complete list of recalled products.

A Postscript

Cronobacter sakazakii was first associated with meningitis in infants in the 1960s. In 2001, the death of an eleven-day old infant in a neonatal intensive care unit (NICU) of a Tennessee hospital was traced to the use of Portagen powdered infant formula manufactured by Mead Johnson. Cronobacter was recovered from nine of forty-eight infants in the NICU.

Following the Mead Johnson incident, the FDA strengthened its surveillance of infant formula manufacturers and improved its lab methods for detecting Cronobacter sakazakii.

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.

Excerpt from the new audiobook edition of TAINTED