Michigan baby formula factory focus of FDA probe after infant illnesses

May 16: Michigan baby formula factory, Abbott, reaches deal with FDA to reopen

A southwest Michigan factory just a few miles from the Indiana border is at the center of an infant formula recall that’s helped fuel shortages across the U.S. and raised concerns about federal oversight of contamination in food production.

Abbott Nutrition, a division of Abbott Laboratories that employs an estimated 420 people in its factory and R&D facility in Sturgis, voluntarily recalled various brands and lot codes of powdered formula — including Similac, the most sold brand in the U.S. — in February.

The recall came five months after an initial complaint that an infant in Minnesota hospitalized with a bacterial infection had consumed Similac from the Sturgis factory. 

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The Food and Drug Administration first inspected the plant last September, when it found contamination risks. By the end of February, the FDA had identified five infants who became seriously ill with bacterial infections after they consumed the formula. Four had been infected with Cronobacter sakazakii  — an infrequent infection that can be deadly for babies — and one had been infected with salmonella. Two of the infected infants, from Ohio, died, according to the FDA.

The company said in a statement this week that while the FDA found cronobacter sakazakii at the plant, it was not near where the products were made and its product testing of formula came back negative for cronobacter sakazakii and salmonella. 

The FDA said it continues to investigate. At the same time, federal officials are trying to increase baby formula production at other U.S. factories to stem a national shortage that began before Similac was removed from store shelves in February.

Potential contamination from infant formula is “very rare,” Dr. Kira Sieplinga, pediatric hospitalist for Spectrum Health in Grand Rapids, told Bridge Michigan in an interview.

While the FDA monitors safety, “the hard part is this factory in Sturgis is responsible for quite a bit of the supply,” Sieplinga said.  

In Michigan, the impact of the recall stretches from fearful parents of infants and idled employees in the shuttered plant to the state health department, which had to change its nutrition subsidy program, which had contracted with Abbott to supply infant formula. (The state’s Women, Infants and Children (WIC) program switched from providing another brand to Similac in November.)

“We’re obviously encouraged that Abbott will be back in production soon,” Sturgis Mayor Jeff Mullins told Bridge. 

Sturgis Chamber of Commerce President Roxanne Persing did not reply to a phone message. Christine Heflin, a quality systems analyst at Abbott,  is listed as a chamber board member.

The Michigan Occupational Safety and Health Administration is among the regulators scrutinizing the plant’s operations. MIOSHA started its health investigation of the site in late April, a spokesperson told Bridge, based on an employee complaint regarding workplace health and safety hazards.

“We cannot provide information on open investigations,” Erica Quealy of MIOSHA said. “Typically, these types of investigations may take several weeks or months to complete.”

The FDA issued its first alert telling consumers to avoid the Similac products on February 17 after the bacteria turned up during an inspection of the Sturgis facility Feb. 1-2, prompting the recall and factory shutdown.

The move set off a scramble at clinics across the state, including a Detroit clinic, which called  every parent to make sure they immediately discarded any formula subject to the recall. 

“It’s super serious — one of the worst” infant infections, said Dr. Eric McGrath, of Wayne Pediatrics. He said he had treated a child with a cronobacter infection years ago — the only one in his 12 years as a pediatric infectious disease specialist.

“The reason that this germ is devastating is that it can cause blood infections and meningitis, and complications that include brain abscesses,”  McGrath said. 

At minimum, a baby with cronobacter infection is hospitalized for three weeks and likely subjected to a spinal tap and other trauma. The child McGrath treated survived, he said, but only after a two-month hospitalization and intensive treatment.

The February inspection followed a visit last September, when the FDA noted Abbott’s factor was not in “clean and sanitary condition.” According to Consumer Reports, the FDA’s September inspection took place after a Minnesota infant was hospitalized for three weeks after ingesting powdered formula linked to the plant. 

Late last month, U.S. Rep. Rosa DeLauro, a Democrat from Connecticut and House appropriations chair, called for an investigation into the FDA’s handling of the investigation. She noted that a whistleblower, who had worked in the factory before being terminated, had sent the FDA a 34-page report in October. 

That report alleged “a series of violations of regulatory requirements” that included failing equipment that allowed bacteria to reach formula. Two Ohio senators also called for an investigation in April.

The Abbott plant’s problems were one of a host of factors fueling the shortage of baby formula. 

The White House this week said the FDA is trying to increase baby formula production to stem the national shortgages driven in part by lack of cow’s milk, packaging and labor. A Congressional hearing on the shortages is  scheduled for May 25, though it’s not yet clear who will testify. 

For now, the factory’s formula production remains closed. Abbott had been running three shifts at the Sturgis plant before the shutdown. The company said in a statement Wednesday that it could resume production within two weeks if the FDA signs off.  

But, Abbott added, it could be six to eight weeks “before product is available on shelves.” 

Investigations

In the September visit by the FDA, investigators found standing water in multiple locations, including outside of a dry blending room where formula is made. A forklift was found in an area where it was not supposed to be due to cross-contamination concerns. And a blowing fan had “extensive debris and dust-like build up.”

The report also said that “personnel working directly with infant formula … did not wash hands thoroughly … after the hands may have become soiled or contaminated.”

The FDA again visited the site for several days starting on January 31, according to one of its reports.

The report said that cronobacter germs were found Feb. 1 and 2 on multiple surfaces of the facility, including medium- and high-care areas. It also indicated earlier testing found it in two finished powdered formulas made in 2019 and 2020.

“You did not establish a system of process controls … to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment,” the FDA said in the spring report.

The report also noted that microorganisms had been found eight times in the factory between 2019 and the early 2022 inspection, and 20 times later in February.

However, the company denied a proven link to the illnesses. 

“After a thorough review of all available data, there is no evidence to link our formulas to these infant illnesses,” Abbott said.

Health implications

Michigan health care providers continue to deal with the potential health concern and the ongoing formula shortage.

McGrath Wednesday said it’s unclear whether efforts to alert parents at the Wayne Pediatrics made a difference.  Many of the clinic’s families receive government assistance through the WIC program. 

He said clinic staff divided phone lists for about 30 parents after the FDA’s recall notice, and offered to replace recalled items. McGrath and another doctor picked up alternative formulas at a Rite Aid and Target, which they gave out in addition to samples at the clinic. A clinic social worker arranged for transportation for parents who had no way to get to the clinic. 

The Michigan Department Agriculture and Rural Development is not involved with the recall or FDA investigation in Sturgis, said spokesperson Jennifer Holton. But MDARD staff checked stores to make sure potentially tainted formula was not reaching consumers. Holton said some recalled product was found on shelves. 

The Michigan Poison and Drug Information Center at Wayne State University fielded calls from worried parents searching for information, said Dr. Varun Vohra, a clinical toxicologist and director of the center, which takes consumer calls around the clock at 800-222-1222.

Parents who may have reason to be concerned about whether their child ingested recalled formula should be watchful for loss of appetite, irritability, fluctuations in body temperature, jaundice, abnormal breathing, including grunting, lethargy, rash, or blood in the urine or stool. They should call 911 immediately in the case of acute symptoms.

“(Access to formula) is usually nothing that we worry about,” said Sieplinga, the Spectrum pediatric specialist. Now, she’s urging parents to avoid hoarding formula, along with not watering down formulas to extend its use. 

Parents with questions about changes in their babies or formula should contact their doctors, she added.

Specifics on the recalled formula can be found on the maker’s webpage here.

Meanwhile, Abbott said in a statement on Friday that it is taking steps to address the formula shortage while production in Sturgis is down by converting other product lines in its Columbus, Ohio, factory to produce Similac liquid ready-to-feed formula. 

It also said it is increasing coupons and rebates for its products “to enable customers to purchase formula, either free or deeply discounted.”