FDA Releases Inspection Reports of Plant That Made Recalled Similac

Following reports of illnesses and deaths among infants who consumed Similac powdered baby formula, the U.S. Food and Drug Administration (FDA) has released inspection reports of the Abbott Nutrition plant in Sturgis, MI where the formula was made. In an unusual move, the agency released three FDA Form 483s from three inspections conducted at Abbott Nutrition’s facility on Sept. 16-24, 2019, Sept. 20-24, 2021, and Jan. 31-March 18, 2022.

Some of the information from these inspections, such as the presence of Cronobacter at the facility and failure to maintain a sanitary manufacturing environment, has been previously reported. But this is the first time that full information from the 2022 inspection, which came after the illnesses and deaths were reported, has been made public.

Among the items that stand out, is the citation that Abbott did not retain a sample of the lot Similac Pro Total Comfort associated with a fatal illness. Further, the report states that Abbott’s investigation of complaints of illness did not include a determination of root causes of contamination, whether a health hazard exists at the plant and the basis for that determination.

Also of note is the citation that states during the two-year period from January 1, 2020, to February 1, 2022, the company identified 310 water events including water leaks, moisture, and condensation in the dry powdered infant formulas production areas.

In food production, water where it shouldn’t be poses a serious food safety risk. This was the case with Cronobacter illnesses associated with another brand of powdered infant formula in 2011 and several outbreaks associated with other foods.

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Cronobacter Illnesses Among Infants Who Consumed Similac

Between September 2021 and January 2022, federal health authorities received reports of four infants from three states who developed Cronobacter sakazakii infections after consuming Similac powdered infant formula made at Abbott Nutrition’s plant in Sturgis, MI. Specifically, the four infants consumed Similac Sensitive, Similac Pro-total Comfort, Similac Advance, and Similac PM 60/40. The illnesses were reported from three states MN (1), OH (2), and (TX). Both infants in Ohio died.

Texas health officials also reported one infant who developed a Salmonella Newport infection after consuming Similac Alimentum. However, that illness was removed from the investigation after the Centers for Disease Control and Prevention (CDC) determined that there was not enough available information to definitively link the Salmonella Newport illness to the recalled infant formula.


Powdered Infant Formula Salmonella Outbreaks

Recalled Similac Products Comsumed by Infants with Cronobacter
Recalled Similac Products Consumed by Infants with Cronobacter.

Cronobacter and Infant Formula

Cronobacter bacteria can live on dry foods. For most adults, Cronobacter does not pose a serious health risk,  but for newborns, infections can be deadly. Cronobacter sakazakii, one of the most virulent Cronobacter strains, is the strain most often associated with invasive Cronobacter infections. In infants, invasive Conobacter infections can cause meningitis, sepsis, and necrotizing enterocolitis, a condition that inflames intestinal tissue, causing it to die

Most Cronobacter infections in infants have been linked epidemiologically to powdered infant formula, according to numerous studies. Unlike liquid baby formula, powdered infant formula is not a sterile product. So it can, and sometimes does, contain harmful bacteria. That’s why, in 2002, the FDA made a recommendation discouraging the use of powdered infant formulas in hospital settings.

An FDA Consumer Advisory, Then a Recall

On February 17, 2021, the FDA announced that along with the CDC and state partners, it was conducting an investigation of the Cronobacter illnesses among infants who consumed Similac. The agency issued a consumer advisory warning consumers not to use Similac, Alimentum and EleCare products made at Abbott Nutrition’s plant in Sturgis, MI. Shortly after the FDA issued this advisory, Abbott Nutrition issued a recall for Similac and other products made at its Sturgis plant.

On February 28, 2022, Abbott Nutrition expanded the recall to include a specialty formula called Similac PM 60/40 with the lot code 27032K800. Specialty powdered infant formulas products are made for infants with special medical needs. This recall expansion was issued after the fourth Cronobacter illness, which was fatal, was reported. The Ohio baby had consumed Similac 60/40.

Two weeks later, the FDA alerted users of other specialty formulas that these products made at Abbott’s Sturgis plant may be contaminated with Cronobacter but are not included in the recall. The FDA said it had chosen not to ask Abbott to recall specialty powdered infant formulas products made at the Sturgis facility. The reason, the agency said, was that “the risk of not having these specialty products available could significantly worsen underlying medical conditions.”  But the FDA wanted to let parents and caregivers who use these specialty products to be aware that there may be some risk of Cronobacter contamination in these products and they should discuss the best course of action with their babies’ doctors

FDA Inspections of Abbott Nutrition’s Plant in Sturgis, MI

On March 22, 2022, the FDA released three FDA Form 483s from inspection in 2019, 2021, and 2022.

These reports reveal that Abbott found Cronobacter in “medium and high care areas” eight times between 2019 and 2022. And 20 times from samples in low, medium, and high care areas collected February 6 – February 20, 2022.

The September 16 – 24, 2019 inspection cites failure to test finished product before distribution. An observation that seems particularly noteworthy as the day after that inspection, September 25, 2019, is one of two dates that the company found Cronobacter in finished product.  In 2019, the product was Similac Alimentum.  On June 22, 2020, the product was Similac for Spit Up.

Inspectors also noted finding water where it shouldn’t be on several occasions which poses a food safety risk. Standing water in the facility was a repeat violation. Inspectors found water in the dryer while the dryer was running Similac Total Comfort; leaking from a valve onto the floor and puddling in various spots throughout the facility.

The reports cite employee hygiene issues such as failure to: wash hands, make sure gloves cover exposed skin of the wrists, and that shoes are cleaned before entering certain areas. They mention failure to keep dedicated equipment for liquid and dry areas, clean and in its dedicated area.

The reports also cite failure to maintain the building in a sanitary fashion and keep equipment in good condition.

Food Safety Lawyers with Experience

If your baby developed a Cronobacter infection and you would like a free consultation with an experienced Food Safety lawyer, please contact us. You can reach us by calling 1-888-377-8900, sending a text to 612-261-0856, or by completing the form below. There is no obligation and we don’t get paid unless we win.

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